FHIR © HL7.org  |  Server Home  |  XIG Home  |  Server Source  |  FHIR  

FHIR IG Statistics: ValueSet/splDocumentCodes

Packagehl7.fhir.us.spl
TypeValueSet
IdsplDocumentCodes
FHIR VersionR5
Sourcehttp://hl7.org/fhir/us/spl/https://build.fhir.org/ig/HL7/fhir-spl/ValueSet-splDocumentCodes.html
URLhttp://hl7.org/fhir/us/spl/ValueSet/splDocumentCodes
Version0.2.8
Statusactive
Date2025-07-07T15:17:39+00:00
NameSPLDocumentCodes
TitleSPL Document Codes
Realmus
Authorityhl7
DescriptionDocument Codes for SPL Product Submission documents
CopyrightThis material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.

Resources that use this resource

StructureDefinition
ProductSubmissionDocumentProductSubmissionDocument

Resources that this resource uses

CodeSystem
loinc.orgLOINC Code System
loinc.orgLOINC codes used in this IG
loinc.orgLogical Observation Identifiers, Names and Codes (LOINC)

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ValueSet splDocumentCodes

  • Include these codes as defined in http://loinc.org
    CodeDisplay
    98075-5ANIMAL CELLS, TISSUES, AND CELL AND TISSUE BASED PRODUCT LABEL
    77647-6ANIMAL COMPOUNDED DRUG LABEL
    104091-4ANIMAL DRUG FOR FURTHER PROCESSING
    86445-4BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING
    53409-9BULK INGREDIENT
    81203-2BULK INGREDIENT - ANIMAL DRUG
    60684-8CELLULAR THERAPY
    58474-8COSMETIC
    103573-2COSMETIC FACILITY REGISTRATION
    104087-2COSMETIC FACILITY REGISTRATION-ABBREVIATED RENEWAL
    104086-4COSMETIC FACILITY REGISTRATION-AMENDMENT
    104089-8COSMETIC FACILITY REGISTRATION-BIENNIAL RENEWAL
    104088-0COSMETIC FACILITY REGISTRATION-CANCELLATION
    103572-4COSMETIC PRODUCT LISTING
    105122-6COSMETIC UPDATE
    104090-6COSMETIC-ABBREVIATED RENEWAL
    58476-3DIETARY SUPPLEMENT
    78744-0DRUG FOR FURTHER PROCESSING
    70097-1ESTABLISHMENT DE-REGISTRATION
    51725-0ESTABLISHMENT REGISTRATION
    89600-1FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION
    99282-6FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION - ANIMAL DRUG
    71743-9GENERIC DRUG FACILITY IDENTIFICATION SUBMISSION
    75031-5HUMAN COMPOUNDED DRUG LABEL
    34390-5HUMAN OTC DRUG LABEL
    34391-3HUMAN PRESCRIPTION DRUG LABEL
    72090-4IDENTIFICATION OF CBER-REGULATED GENERIC DRUG FACILITY
    71446-9INDEXING - BILLING UNIT
    77648-4INDEXING - BIOLOGICAL DRUG SUBSTANCE
    93723-5INDEXING - DRUG INTERACTIONS
    63417-0INDEXING - INDICATION
    93372-1INDEXING - NATIONAL CLINICAL TRIALS NUMBER
    60685-5INDEXING - PHARMACOLOGIC CLASS
    73815-3INDEXING - PRODUCT CONCEPT
    82353-4INDEXING - RISK EVALUATION & MITIGATION STRATEGIES
    64124-1INDEXING - SUBSTANCE
    77288-9INDEXING - WARNING LETTER ALERT
    101437-2INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
    53407-3LICENSE BLOOD INTERMEDIATES/PASTE LABEL
    53408-1LICENSED MINIMALLY MANIPULATED CELLS LABEL
    53406-5LICENSED VACCINE BULK INTERMEDIATE LABEL
    66105-8LOT DISTRIBUTION DATA
    55439-4MEDICAL DEVICE
    58475-5MEDICAL FOOD
    53410-7NO CHANGE NOTIFICATION
    53405-7NON-STANDARDIZED ALLERGENIC LABEL
    69968-6NDC LABELER CODE INACTIVATION
    81204-0NDC LABELER CODE INACTIVATION - ANIMAL DRUG
    72871-7NDC LABELER CODE REQUEST - ANIMAL DRUG
    51726-8NDC/NHRIC LABELER CODE REQUEST
    50577-6OTC ANIMAL DRUG LABEL
    69403-4OTC MEDICAL DEVICE LABEL
    50576-8OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
    50574-3OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL
    50573-5OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL
    53411-5OUT OF BUSINESS NOTIFICATION
    60683-0PLASMA DERIVATIVE
    50578-4PRESCRIPTION ANIMAL DRUG LABEL
    69404-2PRESCRIPTION MEDICAL DEVICE LABEL
    78745-7RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
    85274-9REMS RELEASE
    82351-8RISK EVALUATION & MITIGATION STRATEGIES
    60682-2STANDARDIZED ALLERGENIC
    53404-0VACCINE LABEL
    50575-0VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
    50572-7VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL
    50571-9VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL
    75030-7WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT
    77573-4WITHDRAWAL OF WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT

Source

{
  "resourceType": "ValueSet",
  "id": "splDocumentCodes",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1,
      "_valueInteger": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/us/spl/ValueSet/splDocumentCodes",
  "version": "0.2.8",
  "name": "SPLDocumentCodes",
  "title": "SPL Document Codes",
  "status": "active",
  "experimental": false,
  "date": "2025-07-07T15:17:39+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description": "Document Codes for SPL Product Submission documents",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "US",
          "display": "United States of America"
        }
      ]
    }
  ],
  "copyright": "This material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.",
  "compose": {
    "include": [
      {
        "system": "http://loinc.org",
        "concept": [
          {
            "code": "98075-5",
            "display": "ANIMAL CELLS, TISSUES, AND CELL AND TISSUE BASED PRODUCT LABEL"
          },
          {
            "code": "77647-6",
            "display": "ANIMAL COMPOUNDED DRUG LABEL"
          },
          {
            "code": "104091-4",
            "display": "ANIMAL DRUG FOR FURTHER PROCESSING"
          },
          {
            "code": "86445-4",
            "display": "BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING"
          },
          {
            "code": "53409-9",
            "display": "BULK INGREDIENT"
          },
          {
            "code": "81203-2",
            "display": "BULK INGREDIENT - ANIMAL DRUG"
          },
          {
            "code": "60684-8",
            "display": "CELLULAR THERAPY"
          },
          {
            "code": "58474-8",
            "display": "COSMETIC"
          },
          {
            "code": "103573-2",
            "display": "COSMETIC FACILITY REGISTRATION"
          },
          {
            "code": "104087-2",
            "display": "COSMETIC FACILITY REGISTRATION-ABBREVIATED RENEWAL"
          },
          {
            "code": "104086-4",
            "display": "COSMETIC FACILITY REGISTRATION-AMENDMENT"
          },
          {
            "code": "104089-8",
            "display": "COSMETIC FACILITY REGISTRATION-BIENNIAL RENEWAL"
          },
          {
            "code": "104088-0",
            "display": "COSMETIC FACILITY REGISTRATION-CANCELLATION"
          },
          {
            "code": "103572-4",
            "display": "COSMETIC PRODUCT LISTING"
          },
          {
            "code": "105122-6",
            "display": "COSMETIC UPDATE"
          },
          {
            "code": "104090-6",
            "display": "COSMETIC-ABBREVIATED RENEWAL"
          },
          {
            "code": "58476-3",
            "display": "DIETARY SUPPLEMENT"
          },
          {
            "code": "78744-0",
            "display": "DRUG FOR FURTHER PROCESSING"
          },
          {
            "code": "70097-1",
            "display": "ESTABLISHMENT DE-REGISTRATION"
          },
          {
            "code": "51725-0",
            "display": "ESTABLISHMENT REGISTRATION"
          },
          {
            "code": "89600-1",
            "display": "FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION"
          },
          {
            "code": "99282-6",
            "display": "FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION - ANIMAL DRUG"
          },
          {
            "code": "71743-9",
            "display": "GENERIC DRUG FACILITY IDENTIFICATION SUBMISSION"
          },
          {
            "code": "75031-5",
            "display": "HUMAN COMPOUNDED DRUG LABEL"
          },
          {
            "code": "34390-5",
            "display": "HUMAN OTC DRUG LABEL"
          },
          {
            "code": "34391-3",
            "display": "HUMAN PRESCRIPTION DRUG LABEL"
          },
          {
            "code": "72090-4",
            "display": "IDENTIFICATION OF CBER-REGULATED GENERIC DRUG FACILITY"
          },
          {
            "code": "71446-9",
            "display": "INDEXING - BILLING UNIT"
          },
          {
            "code": "77648-4",
            "display": "INDEXING - BIOLOGICAL DRUG SUBSTANCE"
          },
          {
            "code": "93723-5",
            "display": "INDEXING - DRUG INTERACTIONS"
          },
          {
            "code": "63417-0",
            "display": "INDEXING - INDICATION"
          },
          {
            "code": "93372-1",
            "display": "INDEXING - NATIONAL CLINICAL TRIALS NUMBER"
          },
          {
            "code": "60685-5",
            "display": "INDEXING - PHARMACOLOGIC CLASS"
          },
          {
            "code": "73815-3",
            "display": "INDEXING - PRODUCT CONCEPT"
          },
          {
            "code": "82353-4",
            "display": "INDEXING - RISK EVALUATION & MITIGATION STRATEGIES"
          },
          {
            "code": "64124-1",
            "display": "INDEXING - SUBSTANCE"
          },
          {
            "code": "77288-9",
            "display": "INDEXING - WARNING LETTER ALERT"
          },
          {
            "code": "101437-2",
            "display": "INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL"
          },
          {
            "code": "53407-3",
            "display": "LICENSE BLOOD INTERMEDIATES/PASTE LABEL"
          },
          {
            "code": "53408-1",
            "display": "LICENSED MINIMALLY MANIPULATED CELLS LABEL"
          },
          {
            "code": "53406-5",
            "display": "LICENSED VACCINE BULK INTERMEDIATE LABEL"
          },
          {
            "code": "66105-8",
            "display": "LOT DISTRIBUTION DATA"
          },
          {
            "code": "55439-4",
            "display": "MEDICAL DEVICE"
          },
          {
            "code": "58475-5",
            "display": "MEDICAL FOOD"
          },
          {
            "code": "53410-7",
            "display": "NO CHANGE NOTIFICATION"
          },
          {
            "code": "53405-7",
            "display": "NON-STANDARDIZED ALLERGENIC LABEL"
          },
          {
            "code": "69968-6",
            "display": "NDC LABELER CODE INACTIVATION"
          },
          {
            "code": "81204-0",
            "display": "NDC LABELER CODE INACTIVATION - ANIMAL DRUG"
          },
          {
            "code": "72871-7",
            "display": "NDC LABELER CODE REQUEST - ANIMAL DRUG"
          },
          {
            "code": "51726-8",
            "display": "NDC/NHRIC LABELER CODE REQUEST"
          },
          {
            "code": "50577-6",
            "display": "OTC ANIMAL DRUG LABEL"
          },
          {
            "code": "69403-4",
            "display": "OTC MEDICAL DEVICE LABEL"
          },
          {
            "code": "50576-8",
            "display": "OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"
          },
          {
            "code": "50574-3",
            "display": "OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL"
          },
          {
            "code": "50573-5",
            "display": "OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL"
          },
          {
            "code": "53411-5",
            "display": "OUT OF BUSINESS NOTIFICATION"
          },
          {
            "code": "60683-0",
            "display": "PLASMA DERIVATIVE"
          },
          {
            "code": "50578-4",
            "display": "PRESCRIPTION ANIMAL DRUG LABEL"
          },
          {
            "code": "69404-2",
            "display": "PRESCRIPTION MEDICAL DEVICE LABEL"
          },
          {
            "code": "78745-7",
            "display": "RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL"
          },
          {
            "code": "85274-9",
            "display": "REMS RELEASE"
          },
          {
            "code": "82351-8",
            "display": "RISK EVALUATION & MITIGATION STRATEGIES"
          },
          {
            "code": "60682-2",
            "display": "STANDARDIZED ALLERGENIC"
          },
          {
            "code": "53404-0",
            "display": "VACCINE LABEL"
          },
          {
            "code": "50575-0",
            "display": "VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL"
          },
          {
            "code": "50572-7",
            "display": "VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL"
          },
          {
            "code": "50571-9",
            "display": "VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL"
          },
          {
            "code": "75030-7",
            "display": "WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT"
          },
          {
            "code": "77573-4",
            "display": "WITHDRAWAL OF WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT"
          }
        ]
      }
    ]
  }
}