FHIR IG analytics| Package | hl7.fhir.us.pq-cmc-fda |
| Resource Type | Bundle |
| Id | Bundle-BatchFormulaBundle.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
"resourceType": "Bundle",
"id": "BatchFormulaBundle",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32"
]
},
"identifier": {
"system": "urn:ietf:rfc:3986",
"value": "urn:uuid:a242b79e-b706-49d3-93ba-b4364ab2baa3"
},
"type": "document",
"timestamp": "2024-07-01T12:34:56.789Z",
"entry": [
{
"fullUrl": "urn:uuid:0003c00b-bfc2-4775-8b1c-9f99d5cf1f39",
"resource": {
"resourceType": "Composition",
"id": "0003c00b-bfc2-4775-8b1c-9f99d5cf1f39",
"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_0003c00b-bfc2-4775-8b1c-9f99d5cf1f39\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 0003c00b-bfc2-4775-8b1c-9f99d5cf1f39</b></p><a name=\"0003c00b-bfc2-4775-8b1c-9f99d5cf1f39\"> </a><a name=\"hc0003c00b-bfc2-4775-8b1c-9f99d5cf1f39\"> </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>: BatchFormulaComposition</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>: 2024-07-01 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</p></div>"
},
"identifier": [
{
"value": "BatchFormulaComposition"
}
],
"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": "2024-07-01T12:34:56.789Z",
"author": [
{
"reference": "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
}
],
"title": "Batch formula example",
"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:d0d2df25-5cfa-4417-b8d1-b8147957f53c"
}
]
}
]
}
},
{
"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:e875ef93-a730-4c44-bead-53663ae7f501",
"resource": {
"resourceType": "Organization",
"id": "e875ef93-a730-4c44-bead-53663ae7f501",
"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_e875ef93-a730-4c44-bead-53663ae7f501\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e875ef93-a730-4c44-bead-53663ae7f501</b></p><a name=\"e875ef93-a730-4c44-bead-53663ae7f501\"> </a><a name=\"hce875ef93-a730-4c44-bead-53663ae7f501\"> </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/147275722, FEI/6981397</p><p><b>name</b>: East-West Manufacturing</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>East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, 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": "147275722"
},
{
"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": "6981397"
}
],
"name": "East-West Manufacturing",
"contact": [
{
"address": {
"type": "postal",
"text": "East-West Manufacturing, 100 Stillwater Avenue, Building #2, Bangor, ME, United States",
"line": [
"100 Stillwater Avenue",
"Building #2"
],
"city": "Bangor",
"state": "ME",
"postalCode": "04401",
"country": "USA"
}
}
]
}
},
{
"fullUrl": "urn:uuid:d0d2df25-5cfa-4417-b8d1-b8147957f53c",
"resource": {
"resourceType": "MedicinalProductDefinition",
"id": "d0d2df25-5cfa-4417-b8d1-b8147957f53c",
"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_d0d2df25-5cfa-4417-b8d1-b8147957f53c\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c</b></p><a name=\"d0d2df25-5cfa-4417-b8d1-b8147957f53c\"> </a><a name=\"hcd0d2df25-5cfa-4417-b8d1-b8147957f53c\"> </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>: Oxazepam-Propranolol-BatchFormula-Identification</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42953}\">LIQUID</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-BatchFormulaBundle.html#urn-uuid-249ef22b-d521-4304-a388-6b9035f97b22\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: ATOMOXETINE HYDROCHLORIDE 1mg</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>: ATOMOXETINE HYDROCHLORIDE</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>: 1mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">ATOMOXETINE HYDROCHLORIDE</span></p></blockquote></blockquote></div>"
},
"identifier": [
{
"value": "Oxazepam-Propranolol-BatchFormula-Identification"
}
],
"combinedPharmaceuticalDoseForm": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42953",
"display": "LIQUID"
}
]
},
"route": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C38288",
"display": "ORAL"
}
]
}
],
"comprisedOf": [
{
"reference": "urn:uuid:249ef22b-d521-4304-a388-6b9035f97b22"
}
],
"name": [
{
"productName": "ATOMOXETINE HYDROCHLORIDE 1mg",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C96971",
"display": "Nonproprietary Name"
}
]
},
"part": [
{
"part": "ATOMOXETINE HYDROCHLORIDE",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "SCI"
}
]
}
},
{
"part": "1mg",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "STR"
}
],
"text": "ATOMOXETINE HYDROCHLORIDE"
}
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:249ef22b-d521-4304-a388-6b9035f97b22",
"resource": {
"resourceType": "ManufacturedItemDefinition",
"id": "249ef22b-d521-4304-a388-6b9035f97b22",
"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_249ef22b-d521-4304-a388-6b9035f97b22\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition 249ef22b-d521-4304-a388-6b9035f97b22</b></p><a name=\"249ef22b-d521-4304-a388-6b9035f97b22\"> </a><a name=\"hc249ef22b-d521-4304-a388-6b9035f97b22\"> </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>: Oxazepam-Propranolol-BatchFormula</p><p><b>status</b>: Active</p><p><b>name</b>: ATOMOXETINE HYDROCHLORIDE 1mg</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C45298}\">Liquid</span></p><p><b>manufacturer</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 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>: 50 liter<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeL = 'L')</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 C133990}\">Commercial</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 50 Litres of product, accounting for losses from evaporation and spillage</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 C42986}\">Solution</span></p><p><b>amount</b>: 53.2 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span>, 100 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><blockquote><p><b>constituent</b></p><p><b>Product Batch Strength Textual Extension</b>: 5% atomexetine hydrochloride solution</p><p><b>amount</b>: 25.42 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.0477 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</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-BatchFormulaBundle.html#urn-uuid-1c1a2a23-1fd7-4487-9682-49877f9f9f77\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 20.5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.0385 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</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-BatchFormulaBundle.html#urn-uuid-12cce82f-8595-4860-b7ca-06c9ec0327f2\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.0094 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</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-BatchFormulaBundle.html#urn-uuid-45eb4f05-83d9-4819-bb60-96c7c5ce2b76\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 2.27 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span>, 4.2652 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</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-BatchFormulaBundle.html#urn-uuid-29c0ee76-f62f-41d3-b761-73d5f205e552\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 150 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.2818 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</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-BatchFormulaBundle.html#urn-uuid-44fad9fd-826a-4f0c-9f25-e0a78d1c4269\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 50.75 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span>, 95.3572 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</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-BatchFormulaBundle.html#urn-uuid-d0574580-7694-4a36-8a27-5bdbccfc5557\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 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:\">solution</span></td></tr></table></blockquote></div>"
},
"identifier": [
{
"value": "Oxazepam-Propranolol-BatchFormula"
}
],
"status": "active",
"name": "ATOMOXETINE HYDROCHLORIDE 1mg",
"manufacturedDoseForm": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C45298",
"display": "Liquid"
}
]
},
"manufacturer": [
{
"reference": "urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"
}
],
"property": [
{
"type": {
"text": "Batch Quantity"
},
"valueQuantity": {
"value": 50,
"unit": "liter",
"system": "http://unitsofmeasure.org",
"code": "L"
}
},
{
"type": {
"text": "Batch Utilization"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C133990",
"display": "Commercial"
}
]
}
},
{
"type": {
"text": "Batch Formula Additional Information"
},
"valueMarkdown": "Makes 50 Litres of product, accounting for losses from evaporation and spillage"
}
],
"component": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C42986",
"display": "Solution"
}
]
},
"amount": [
{
"value": 53.2,
"unit": "kilogram",
"system": "http://unitsofmeasure.org",
"code": "kg"
},
{
"value": 100,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"constituent": [
{
"extension": [
{
"url": "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-product-batch-strength-textual-extension",
"valueString": "5% atomexetine hydrochloride solution"
}
],
"amount": [
{
"value": 25.42,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 0.0477,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77"
}
}
]
},
{
"amount": [
{
"value": 20.5,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 0.0385,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2"
}
}
]
},
{
"amount": [
{
"value": 5,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 0.0094,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76"
}
}
]
},
{
"amount": [
{
"value": 2.27,
"unit": "kilogram",
"system": "http://unitsofmeasure.org",
"code": "kg"
},
{
"value": 4.2652,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552"
}
}
]
},
{
"amount": [
{
"value": 150,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
},
{
"value": 0.2818,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269"
}
}
]
},
{
"amount": [
{
"value": 50.75,
"unit": "kilogram",
"system": "http://unitsofmeasure.org",
"code": "kg"
},
{
"value": 95.3572,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
],
"hasIngredient": [
{
"reference": {
"reference": "urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557"
}
}
]
}
],
"property": [
{
"type": {
"text": "Product Part Identifier"
},
"valueCodeableConcept": {
"text": "solution"
}
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77",
"resource": {
"resourceType": "Ingredient",
"id": "1c1a2a23-1fd7-4487-9682-49877f9f9f77",
"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_1c1a2a23-1fd7-4487-9682-49877f9f9f77\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 1c1a2a23-1fd7-4487-9682-49877f9f9f77</b></p><a name=\"1c1a2a23-1fd7-4487-9682-49877f9f9f77\"> </a><a name=\"hc1c1a2a23-1fd7-4487-9682-49877f9f9f77\"> </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>: AtomexetineHydrochlorideBFIngredient</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-BatchFormulaBundle.html#urn-uuid-717d868e-6696-4ebb-adf4-63eadb3bf058\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 25.42 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0477 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "AtomexetineHydrochlorideBFIngredient"
},
"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:717d868e-6696-4ebb-adf4-63eadb3bf058"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 25.42,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 0.0477,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "717d868e-6696-4ebb-adf4-63eadb3bf058",
"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_717d868e-6696-4ebb-adf4-63eadb3bf058\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058</b></p><a name=\"717d868e-6696-4ebb-adf4-63eadb3bf058\"> </a><a name=\"hc717d868e-6696-4ebb-adf4-63eadb3bf058\"> </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-BatchFormulaBundle.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 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 57WVB6I2W0}\">57WVB6I2W0</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>ATOMOXETINE HYDROCHLORIDE</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:e875ef93-a730-4c44-bead-53663ae7f501"
}
],
"code": [
{
"code": {
"coding": [
{
"system": "http://fdasis.nlm.nih.gov",
"code": "57WVB6I2W0"
}
]
}
}
],
"name": [
{
"name": "ATOMOXETINE HYDROCHLORIDE",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C203355",
"display": "GSRS Preferred Term"
}
]
},
"preferred": true
}
]
}
},
{
"fullUrl": "urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2",
"resource": {
"resourceType": "Ingredient",
"id": "12cce82f-8595-4860-b7ca-06c9ec0327f2",
"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_12cce82f-8595-4860-b7ca-06c9ec0327f2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2</b></p><a name=\"12cce82f-8595-4860-b7ca-06c9ec0327f2\"> </a><a name=\"hc12cce82f-8595-4860-b7ca-06c9ec0327f2\"> </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>: GlacialAceticAcidBFIngredient</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-BatchFormulaBundle.html#urn-uuid-45942749-64db-4f91-88c3-51adb680fed1\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 20.5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0385 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "GlacialAceticAcidBFIngredient"
},
"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:45942749-64db-4f91-88c3-51adb680fed1"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 20.5,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 0.0385,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:45942749-64db-4f91-88c3-51adb680fed1",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "45942749-64db-4f91-88c3-51adb680fed1",
"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_45942749-64db-4f91-88c3-51adb680fed1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 45942749-64db-4f91-88c3-51adb680fed1</b></p><a name=\"45942749-64db-4f91-88c3-51adb680fed1\"> </a><a name=\"hc45942749-64db-4f91-88c3-51adb680fed1\"> </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 Q40Q9N063P}\">Q40Q9N063P</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>ACETIC ACID</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": "Q40Q9N063P"
}
]
}
}
],
"name": [
{
"name": "ACETIC ACID",
"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:45eb4f05-83d9-4819-bb60-96c7c5ce2b76",
"resource": {
"resourceType": "Ingredient",
"id": "45eb4f05-83d9-4819-bb60-96c7c5ce2b76",
"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_45eb4f05-83d9-4819-bb60-96c7c5ce2b76\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 45eb4f05-83d9-4819-bb60-96c7c5ce2b76</b></p><a name=\"45eb4f05-83d9-4819-bb60-96c7c5ce2b76\"> </a><a name=\"hc45eb4f05-83d9-4819-bb60-96c7c5ce2b76\"> </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>: AnhydrousSodiumAcetateBFIngredient</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-BatchFormulaBundle.html#urn-uuid-07c598ee-3dcf-45b7-b4e5-b24812c22aff\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0094 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "AnhydrousSodiumAcetateBFIngredient"
},
"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:07c598ee-3dcf-45b7-b4e5-b24812c22aff"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 5,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 0.0094,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "07c598ee-3dcf-45b7-b4e5-b24812c22aff",
"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_07c598ee-3dcf-45b7-b4e5-b24812c22aff\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 07c598ee-3dcf-45b7-b4e5-b24812c22aff</b></p><a name=\"07c598ee-3dcf-45b7-b4e5-b24812c22aff\"> </a><a name=\"hc07c598ee-3dcf-45b7-b4e5-b24812c22aff\"> </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 NVG71ZZ7P0}\">NVG71ZZ7P0</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>SODIUM ACETATE ANHYDROUS</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": "NVG71ZZ7P0"
}
]
}
}
],
"name": [
{
"name": "SODIUM ACETATE ANHYDROUS",
"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:29c0ee76-f62f-41d3-b761-73d5f205e552",
"resource": {
"resourceType": "Ingredient",
"id": "29c0ee76-f62f-41d3-b761-73d5f205e552",
"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_29c0ee76-f62f-41d3-b761-73d5f205e552\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552</b></p><a name=\"29c0ee76-f62f-41d3-b761-73d5f205e552\"> </a><a name=\"hc29c0ee76-f62f-41d3-b761-73d5f205e552\"> </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>: MannitolBFIngredient</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-BatchFormulaBundle.html#urn-uuid-a339a562-e325-4ce6-a830-d25c27b5e2da\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 2.27 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 4.2652 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "MannitolBFIngredient"
},
"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:a339a562-e325-4ce6-a830-d25c27b5e2da"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 2.27,
"unit": "kilogram",
"system": "http://unitsofmeasure.org",
"code": "kg"
}
},
{
"concentrationQuantity": {
"value": 4.2652,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "a339a562-e325-4ce6-a830-d25c27b5e2da",
"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_a339a562-e325-4ce6-a830-d25c27b5e2da\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da</b></p><a name=\"a339a562-e325-4ce6-a830-d25c27b5e2da\"> </a><a name=\"hca339a562-e325-4ce6-a830-d25c27b5e2da\"> </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 3OWL53L36A}\">3OWL53L36A</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>MANNITOL</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": "3OWL53L36A"
}
]
}
}
],
"name": [
{
"name": "MANNITOL",
"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:44fad9fd-826a-4f0c-9f25-e0a78d1c4269",
"resource": {
"resourceType": "Ingredient",
"id": "44fad9fd-826a-4f0c-9f25-e0a78d1c4269",
"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_44fad9fd-826a-4f0c-9f25-e0a78d1c4269\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 44fad9fd-826a-4f0c-9f25-e0a78d1c4269</b></p><a name=\"44fad9fd-826a-4f0c-9f25-e0a78d1c4269\"> </a><a name=\"hc44fad9fd-826a-4f0c-9f25-e0a78d1c4269\"> </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>: MetacresolBFIngredient</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-BatchFormulaBundle.html#urn-uuid-c75df5fb-e962-43a6-9dd3-c6682da10a7e\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 150 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.2818 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier": {
"value": "MetacresolBFIngredient"
},
"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:c75df5fb-e962-43a6-9dd3-c6682da10a7e"
}
},
"strength": [
{
"concentrationQuantity": {
"value": 150,
"unit": "gram",
"system": "http://unitsofmeasure.org",
"code": "g"
}
},
{
"concentrationQuantity": {
"value": 0.2818,
"unit": "percent",
"system": "http://unitsofmeasure.org",
"code": "%"
}
}
]
}
}
},
{
"fullUrl": "urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "c75df5fb-e962-43a6-9dd3-c6682da10a7e",
"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_c75df5fb-e962-43a6-9dd3-c6682da10a7e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition c75df5fb-e962-43a6-9dd3-c6682da10a7e</b></p><a name=\"c75df5fb-e962-43a6-9dd3-c6682da10a7e\"> </a><a name=\"hcc75df5fb-e962-43a6-9dd3-c6682da10a7e\"> </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 GGO4Y809LO}\">GGO4Y809LO</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>METACRESOL</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": "GGO4Y809LO"
}
]
}
}
],
"name": [
{
"name": "METACRESOL",
"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:d0574580-7694-4a36-8a27-5bdbccfc5557",
"resource": {
"resourceType": "Ingredient",
"id": "d0574580-7694-4a36-8a27-5bdbccfc5557",
"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_d0574580-7694-4a36-8a27-5bdbccfc5557\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient d0574580-7694-4a36-8a27-5bdbccfc5557</b></p><a name=\"d0574580-7694-4a36-8a27-5bdbccfc5557\"> </a><a name=\"hcd0574580-7694-4a36-8a27-5bdbccfc5557\"> </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-BatchFormulaBundle.html#urn-uuid-c4e5b7c6-2e52-48e3-813b-d227cf29329b\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 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:c4e5b7c6-2e52-48e3-813b-d227cf29329b"
}
},
"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:c4e5b7c6-2e52-48e3-813b-d227cf29329b",
"resource": {
"resourceType": "SubstanceDefinition",
"id": "c4e5b7c6-2e52-48e3-813b-d227cf29329b",
"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_c4e5b7c6-2e52-48e3-813b-d227cf29329b\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition c4e5b7c6-2e52-48e3-813b-d227cf29329b</b></p><a name=\"c4e5b7c6-2e52-48e3-813b-d227cf29329b\"> </a><a name=\"hcc4e5b7c6-2e52-48e3-813b-d227cf29329b\"> </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"
}
]
}
}
}
}
]
}