FHIR IG analytics| Package | hl7.fhir.us.pq-cmc-fda |
| Resource Type | Bundle |
| Id | Bundle-BatchFormulaBundle2Layer.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "BatchFormulaBundle2Layer",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32"
]
},
"identifier": {
"system": "urn:ietf:rfc:3986",
"value": "urn:uuid:49d3b79e-b436-a242-93ba-b706b4364ab2"
},
"type": "document",
"timestamp": "2024-08-29T12:34:56.789Z",
"entry": [
{
"fullUrl": "urn:uuid:c00b0003-c2bf-7547-8b1c-f1f399f99d5c",
"resource": {
"resourceType": "Composition",
"id": "c00b0003-c2bf-7547-8b1c-f1f399f99d5c",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_c00b0003-c2bf-7547-8b1c-f1f399f99d5c\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition c00b0003-c2bf-7547-8b1c-f1f399f99d5c</b></p><a name=\"c00b0003-c2bf-7547-8b1c-f1f399f99d5c\"> </a><a name=\"hcc00b0003-c2bf-7547-8b1c-f1f399f99d5c\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-32p32.html\">eCTD Batch Formula</a></p></div><p><b>identifier</b>: BatchFormulaComposition2layer</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.3.2}\">m3.2.p.3.2 batch formula</span></p><p><b>date</b>: 2024-08-01 12:34:56+0000</p><p><b>author</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Batch formula example two layer tablet</p></div>"
},
"identifier": [
{
"value": "BatchFormulaComposition2layer"
}
],
"status": "final",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.p.3.2",
"display": "m3.2.p.3.2 batch formula"
}
]
},
"date": "2024-08-01T12:34:56.789Z",
"author": [
{
"reference": "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
}
],
"title": "Batch formula example two layer tablet",
"section": [
{
"title": "Batch Formula",
"code": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/ICHContextOfUse",
"code": "ich_3.2.p.3.2",
"display": "m3.2.p.3.2 batch formula"
}
]
},
"entry": [
{
"reference": "urn:uuid:f0f3ff35-5cfa-6617-b8f1-b8167957f53c"
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
"resource": {
"resourceType": "Organization",
"id": "4f3e9af1-306b-4fad-bf04-7881400b266a",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265222"
}
],
"name": "Wunderwerke",
"contact": [
{
"address": {
"type": "postal",
"text": "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478",
"line": [
"123 Scenic Road"
],
"city": "Bridgeport",
"state": "CT",
"postalCode": "65478",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7",
"resource": {
"resourceType": "Organization",
"id": "b69435a0-45c6-4d44-9fde-b354e17408d7",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_b69435a0-45c6-4d44-9fde-b354e17408d7\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7</b></p><a name=\"b69435a0-45c6-4d44-9fde-b354e17408d7\"> </a><a name=\"hcb69435a0-45c6-4d44-9fde-b354e17408d7\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Large Life</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>123 Broad Way, New York, NY, United States</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265222"
}
],
"name": "Large Life",
"contact": [
{
"address": {
"type": "postal",
"text": "123 Broad Way, New York, NY, United States",
"line": [
"123 Broad Way"
],
"city": "New York",
"state": "NY",
"postalCode": "10020",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:f0f3ff35-5cfa-6617-b8f1-b8167957f53c",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "f0f3ff35-5cfa-6617-b8f1-b8167957f53c",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_f0f3ff35-5cfa-6617-b8f1-b8167957f53c\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c</b></p><a name=\"f0f3ff35-5cfa-6617-b8f1-b8167957f53c\"> </a><a name=\"hcf0f3ff35-5cfa-6617-b8f1-b8167957f53c\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-batch-formula-product.html\">Batch Formula Drug Product Identification</a></p></div><p><b>identifier</b>: ASPIRIN-ACETAMINOPHEN-Identification</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42964}\">TABLET, MULTILAYER</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><p><b>comprisedOf</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-8a3e11d9-4323-43c4-be00-8f0ea1837070\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Nonproprietary Name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ASPIRIN</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 200mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">ASPIRIN</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: ACETAMINOPHEN</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 300mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">ACETAMINOPHEN</span></p></blockquote></blockquote></div>"
},
"identifier": [
{
"value": "ASPIRIN-ACETAMINOPHEN-Identification"
}
],
"combinedPharmaceuticalDoseForm": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42964",
"display": "TABLET, MULTILAYER"
}
]
},
"route": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C38288",
"display": "ORAL"
}
]
}
],
"comprisedOf": [
{
"reference": "urn:uuid:8a3e11d9-4323-43c4-be00-8f0ea1837070"
}
],
"name": [
{
"productName": "ASPIRIN 200mg, ACETAMINOPHEN 300mg",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C96971",
"display": "Nonproprietary Name"
}
]
},
"part": [
{
"part": "ASPIRIN",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "SCI"
}
]
}
},
{
"part": "200mg",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "STR"
}
],
"text": "ASPIRIN"
}
},
{
"part": "ACETAMINOPHEN",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "SCI"
}
]
}
},
{
"part": "300mg",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "STR"
}
],
"text": "ACETAMINOPHEN"
}
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:8a3e11d9-4323-43c4-be00-8f0ea1837070",
"resource": {
"resourceType": "ManufacturedItemDefinition",
"id": "8a3e11d9-4323-43c4-be00-8f0ea1837070",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula"
]
},
"text": {
"status": "extensions",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_8a3e11d9-4323-43c4-be00-8f0ea1837070\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070</b></p><a name=\"8a3e11d9-4323-43c4-be00-8f0ea1837070\"> </a><a name=\"hc8a3e11d9-4323-43c4-be00-8f0ea1837070\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-product-batch-formula.html\">Drug Product Batch Formula</a></p></div><p><b>identifier</b>: ASPIRIN-ACETAMINOPHEN</p><p><b>status</b>: Active</p><p><b>name</b>: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C154605}\">Tablet</span></p><p><b>manufacturer</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-b69435a0-45c6-4d44-9fde-b354e17408d7\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:\">Batch Quantity</span></p><p><b>value</b>: 2000 tablets<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code{tbl} = '{tbl}')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:\">Batch Utilization</span></p><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C133991}\">Development</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:\">Batch Formula Additional Information</span></p><p><b>value</b>: </p><div><p>Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation</p>\n</div></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C66831}\">Layer</span></p><p><b>amount</b>: 925.97 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 38.55 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>amount</b>: 400 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 43.1 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203881}\">Purple Layer</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-d4713a90-38d1-49e5-a977-78c63e518562\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 524.01 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 56.59 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203883}\">Purple Layer</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-9973ba9a-b257-425a-8fb9-6dcfe379ca08\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 203.71 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 22 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}\">Purple Layer</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-4e394a0c-4b25-492e-aac7-0faf121ffc4f\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><blockquote><p><b>Overage Extension</b></p><ul><li>proportionDecimal: 0.02</li><li>justification: </li></ul></blockquote><div><p>Evaporation</p>\n</div><p><b>amount</b>: 311.68 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 33 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}\">Purple Layer</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-95648837-ec81-42d9-970c-eac390f2f604\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Product Part Identifier</span></td><td><span title=\"Codes:\">Purple Layer</span></td></tr></table></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C66831}\">Layer</span></p><p><b>amount</b>: 1476.03 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 61.45 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>amount</b>: 600.01 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 40.65 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203881}\">Example1Drug_LayerB</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-fbd464cc-2511-4a3a-b058-3cec4fffd14f\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 876.02 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 59.35 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203883}\">Example1Drug_LayerB</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-9973ba9a-b257-425a-8fb9-6dcfe379ca08\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 369.01 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 25 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><p><b>location</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203882}\">Example1Drug_LayerB</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-95648837-ec81-42d9-970c-eac390f2f604\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Product Part Identifier</span></td><td><span title=\"Codes:\">Example1Drug_LayerB</span></td></tr></table></blockquote></div>"
},
"identifier": [
{
"value": "ASPIRIN-ACETAMINOPHEN"
}
],
"status": "active",
"name": "ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets",
"manufacturedDoseForm": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C154605",
"display": "Tablet"
}
]
},
"manufacturer": [
{
"reference": "urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7"
}
],
"property": [
{
"type": {
"text": "Batch Quantity"
},
"valueQuantity": {
"value": 2000,
"unit": "tablets",
"system": "http://unitsofmeasure.org",
"code": "{tbl}"
}
},
{
"type": {
"text": "Batch Utilization"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C133991",
"display": "Development"
}
]
}
},
{
"type": {
"text": "Batch Formula Additional Information"
},
"valueMarkdown": "Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation"
}
],
"component": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C66831",
"display": "Layer"
}
]
},
"amount": [
{
"value": 925.97,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 38.55,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"constituent": [
{
"amount": [
{
"value": 400,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 43.1,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203881",
"display": "Active core/granulate"
}
],
"text": "Purple Layer"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562"
}
}
]
},
{
"amount": [
{
"value": 524.01,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 56.59,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203883",
"display": "Intragranular"
}
],
"text": "Purple Layer"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"
}
}
]
},
{
"amount": [
{
"value": 203.71,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 22,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203882",
"display": "Extragranular"
}
],
"text": "Purple Layer"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f"
}
}
]
},
{
"extension": [
{
"extension": [
{
"url": "proportionDecimal",
"valueDecimal": 0.02
},
{
"url": "justification",
"valueMarkdown": "Evaporation"
}
],
"url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension"
}
],
"amount": [
{
"value": 311.68,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 33,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203882",
"display": "Extragranular"
}
],
"text": "Purple Layer"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"
}
}
]
}
],
"property": [
{
"type": {
"text": "Product Part Identifier"
},
"valueCodeableConcept": {
"text": "Purple Layer"
}
}
]
},
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C66831",
"display": "Layer"
}
]
},
"amount": [
{
"value": 1476.03,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 61.45,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"constituent": [
{
"amount": [
{
"value": 600.01,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 40.65,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203881",
"display": "Active core/granulate"
}
],
"text": "Example1Drug_LayerB"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f"
}
}
]
},
{
"amount": [
{
"value": 876.02,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 59.35,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203883",
"display": "Intragranular"
}
],
"text": "Example1Drug_LayerB"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08"
}
}
]
},
{
"amount": [
{
"value": 369.01,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 25,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"location": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203882",
"display": "Extragranular"
}
],
"text": "Example1Drug_LayerB"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:95648837-ec81-42d9-970c-eac390f2f604"
}
}
]
}
],
"property": [
{
"type": {
"text": "Product Part Identifier"
},
"valueCodeableConcept": {
"text": "Example1Drug_LayerB"
}
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:d4713a90-38d1-49e5-a977-78c63e518562",
"resource": {
"resourceType": "Ingredient",
"id": "d4713a90-38d1-49e5-a977-78c63e518562",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_d4713a90-38d1-49e5-a977-78c63e518562\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient d4713a90-38d1-49e5-a977-78c63e518562</b></p><a name=\"d4713a90-38d1-49e5-a977-78c63e518562\"> </a><a name=\"hcd4713a90-38d1-49e5-a977-78c63e518562\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-dp-ingredient.html\">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: Asprin - Ingredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}\">Active Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-cbb54715-3928-4e3f-9abe-32914f694957\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 400 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 10.4 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "Asprin - Ingredient"
},
"status": "active",
"role": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C82533",
"display": "Active Ingredient"
}
]
},
"substance": {
"code": {
"reference": {
"reference": "urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 400,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 10.4,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:fbd464cc-2511-4a3a-b058-3cec4fffd14f",
"resource": {
"resourceType": "Ingredient",
"id": "fbd464cc-2511-4a3a-b058-3cec4fffd14f",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_fbd464cc-2511-4a3a-b058-3cec4fffd14f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient fbd464cc-2511-4a3a-b058-3cec4fffd14f</b></p><a name=\"fbd464cc-2511-4a3a-b058-3cec4fffd14f\"> </a><a name=\"hcfbd464cc-2511-4a3a-b058-3cec4fffd14f\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-dp-ingredient.html\">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: AcetaminophenIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}\">Active Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-ca1ff85f-3f05-46be-8cc4-30b076d88c13\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 600 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 25 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "AcetaminophenIngredient"
},
"status": "active",
"role": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C82533",
"display": "Active Ingredient"
}
]
},
"substance": {
"code": {
"reference": {
"reference": "urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 600,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 25,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:9973ba9a-b257-425a-8fb9-6dcfe379ca08",
"resource": {
"resourceType": "Ingredient",
"id": "9973ba9a-b257-425a-8fb9-6dcfe379ca08",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_9973ba9a-b257-425a-8fb9-6dcfe379ca08\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 9973ba9a-b257-425a-8fb9-6dcfe379ca08</b></p><a name=\"9973ba9a-b257-425a-8fb9-6dcfe379ca08\"> </a><a name=\"hc9973ba9a-b257-425a-8fb9-6dcfe379ca08\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-dp-ingredient.html\">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: MaizeStarchIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-99f4a24f-880f-45f1-8364-8e4e03977b2e\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 1400.03 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 58.28 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "MaizeStarchIngredient"
},
"status": "active",
"role": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42637",
"display": "Inactive Ingredient"
}
]
},
"substance": {
"code": {
"reference": {
"reference": "urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 1400.03,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 58.28,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:4e394a0c-4b25-492e-aac7-0faf121ffc4f",
"resource": {
"resourceType": "Ingredient",
"id": "4e394a0c-4b25-492e-aac7-0faf121ffc4f",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_4e394a0c-4b25-492e-aac7-0faf121ffc4f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 4e394a0c-4b25-492e-aac7-0faf121ffc4f</b></p><a name=\"4e394a0c-4b25-492e-aac7-0faf121ffc4f\"> </a><a name=\"hc4e394a0c-4b25-492e-aac7-0faf121ffc4f\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-dp-ingredient.html\">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: GrapeskinIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-a4624559-6c4f-4e90-996d-bc3bf2f5a3f4\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 203.71 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 8.48 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "GrapeskinIngredient"
},
"status": "active",
"role": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42637",
"display": "Inactive Ingredient"
}
]
},
"substance": {
"code": {
"reference": {
"reference": "urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 203.71,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 8.48,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:95648837-ec81-42d9-970c-eac390f2f604",
"resource": {
"resourceType": "Ingredient",
"id": "95648837-ec81-42d9-970c-eac390f2f604",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_95648837-ec81-42d9-970c-eac390f2f604\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604</b></p><a name=\"95648837-ec81-42d9-970c-eac390f2f604\"> </a><a name=\"hc95648837-ec81-42d9-970c-eac390f2f604\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-dp-ingredient.html\">Drug Product Batch Formula Ingredient</a></p></div><p><b>identifier</b>: WaterBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-254742fb-7b5b-49f5-b4af-e0d14d81f2f6\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 50.75 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 95.3572 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "WaterBFIngredient"
},
"status": "active",
"role": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42637",
"display": "Inactive Ingredient"
}
]
},
"substance": {
"code": {
"reference": {
"reference": "urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 50.75,
"unit": "kilogram",
"system": "http://unitsofmeasure.org",
"code": "kg"
}
},
{
"concentrationQuantity": {
"value": 95.3572,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:cbb54715-3928-4e3f-9abe-32914f694957",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "cbb54715-3928-4e3f-9abe-32914f694957",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_cbb54715-3928-4e3f-9abe-32914f694957\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition cbb54715-3928-4e3f-9abe-32914f694957</b></p><a name=\"cbb54715-3928-4e3f-9abe-32914f694957\"> </a><a name=\"hccbb54715-3928-4e3f-9abe-32914f694957\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Drug Substance Handle</a></p></div><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-e165f057-5eed-4e64-8328-4438fc88fb1b\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov R16CO5Y76E}\">R16CO5Y76E</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>ASPIRIN</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
},
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134006",
"display": "USP-NF"
}
]
}
],
"manufacturer": [
{
"reference": "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b"
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "R16CO5Y76E"
}
]
}
}
],
"name": [
{
"name": "ASPIRIN",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
]
}
},
{
"fullUrl": "urn:uuid:ca1ff85f-3f05-46be-8cc4-30b076d88c13",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "ca1ff85f-3f05-46be-8cc4-30b076d88c13",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_ca1ff85f-3f05-46be-8cc4-30b076d88c13\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition ca1ff85f-3f05-46be-8cc4-30b076d88c13</b></p><a name=\"ca1ff85f-3f05-46be-8cc4-30b076d88c13\"> </a><a name=\"hcca1ff85f-3f05-46be-8cc4-30b076d88c13\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Drug Substance Handle</a></p></div><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-BatchFormulaBundle2Layer.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 362O9ITL9D}\">362O9ITL9D</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>ACETAMINOPHEN</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
},
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134006",
"display": "USP-NF"
}
]
}
],
"manufacturer": [
{
"reference": "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "362O9ITL9D"
}
]
}
}
],
"name": [
{
"name": "ACETAMINOPHEN",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
]
}
},
{
"fullUrl": "urn:uuid:99f4a24f-880f-45f1-8364-8e4e03977b2e",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "99f4a24f-880f-45f1-8364-8e4e03977b2e",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_99f4a24f-880f-45f1-8364-8e4e03977b2e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 99f4a24f-880f-45f1-8364-8e4e03977b2e</b></p><a name=\"99f4a24f-880f-45f1-8364-8e4e03977b2e\"> </a><a name=\"hc99f4a24f-880f-45f1-8364-8e4e03977b2e\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45305}\">Mixture</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}\">Company Standard</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov O8232NY3SJ}\">O8232NY3SJ</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>STARCH, CORN</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45305",
"display": "Mixture"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134009",
"display": "Company Standard"
}
]
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "O8232NY3SJ"
}
]
}
}
],
"name": [
{
"name": "STARCH, CORN",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
],
"sourceMaterial": {
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
}
}
},
{
"fullUrl": "urn:uuid:a4624559-6c4f-4e90-996d-bc3bf2f5a3f4",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "a4624559-6c4f-4e90-996d-bc3bf2f5a3f4",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_a4624559-6c4f-4e90-996d-bc3bf2f5a3f4\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition a4624559-6c4f-4e90-996d-bc3bf2f5a3f4</b></p><a name=\"a4624559-6c4f-4e90-996d-bc3bf2f5a3f4\"> </a><a name=\"hca4624559-6c4f-4e90-996d-bc3bf2f5a3f4\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45305}\">Mixture</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176793}\">BP</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 3GOV20705G}\">3GOV20705G</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WINE GRAPE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C14258}\">Plant</span></td><td><span title=\"Codes:\">vitis</span></td><td><span title=\"Codes:\">vinifera</span></td><td><span title=\"Codes:\">fruit skin</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 ITA}\">Italy</span></td></tr></table></div>"
},
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45305",
"display": "Mixture"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C176793",
"display": "BP"
}
]
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "3GOV20705G"
}
]
}
}
],
"name": [
{
"name": "WINE GRAPE",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
],
"sourceMaterial": {
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C14258",
"display": "Plant"
}
]
},
"genus": {
"text": "vitis"
},
"species": {
"text": "vinifera"
},
"part": {
"text": "fruit skin"
},
"countryOfOrigin": [
{
"coding": [
{
"system": "urn:iso:std:iso:3166",
"code": "ITA",
"display": "Italy"
}
]
}
]
}
}
},
{
"fullUrl": "urn:uuid:254742fb-7b5b-49f5-b4af-e0d14d81f2f6",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "254742fb-7b5b-49f5-b4af-e0d14d81f2f6",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_254742fb-7b5b-49f5-b4af-e0d14d81f2f6\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 254742fb-7b5b-49f5-b4af-e0d14d81f2f6</b></p><a name=\"254742fb-7b5b-49f5-b4af-e0d14d81f2f6\"> </a><a name=\"hc254742fb-7b5b-49f5-b4af-e0d14d81f2f6\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-excipient.html\">Excipient Drug Substance</a></p></div><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}\">059QF0KO0R</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WATER</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
],
"grade": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134006",
"display": "USP-NF"
}
]
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "059QF0KO0R"
}
]
}
}
],
"name": [
{
"name": "WATER",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
],
"sourceMaterial": {
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C48807",
"display": "Chemical"
}
]
}
}
}
},
{
"fullUrl": "urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
"resource": {
"resourceType": "Organization",
"id": "4b565cf3-5353-48af-8cd6-5ccf4e9fd579",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name=\"4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><a name=\"hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "783452221"
},
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134004",
"display": "FEI"
}
]
},
"system": "urn:oid:2.16.840.1.113883.4.82",
"value": "6913973"
}
],
"name": "Manufacturing Site (J. Jones Research)",
"contact": [
{
"address": {
"type": "postal",
"text": "Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States",
"line": [
"444 Grant Street"
],
"city": "Bedford",
"state": "NY",
"postalCode": "15600",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:e165f057-5eed-4e64-8328-4438fc88fb1b",
"resource": {
"resourceType": "Organization",
"id": "e165f057-5eed-4e64-8328-4438fc88fb1b",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e165f057-5eed-4e64-8328-4438fc88fb1b\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b</b></p><a name=\"e165f057-5eed-4e64-8328-4438fc88fb1b\"> </a><a name=\"hce165f057-5eed-4e64-8328-4438fc88fb1b\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Vandechemie</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265222"
}
],
"name": "Vandechemie",
"contact": [
{
"address": {
"type": "postal",
"text": "Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium",
"line": [
"Ruzettelaan 39234"
],
"city": "Blankenberge",
"postalCode": "8370",
"country": "BEL"
}
}
]
}
}
]
}