XIG: ValueSet/splDocumentCodes

FHIR IG Statistics: ValueSet/splDocumentCodes

Package	hl7.fhir.us.spl
Resource Type	ValueSet
Id	splDocumentCodes
FHIR Version	R5
Source	http://hl7.org/fhir/us/spl/https://build.fhir.org/ig/HL7/fhir-spl/ValueSet-splDocumentCodes.html
URL	http://hl7.org/fhir/us/spl/ValueSet/splDocumentCodes
Version	0.2.8
Status	active
Date	2025-07-25T16:21:31+00:00
Name	SPLDocumentCodes
Title	SPL Document Codes
Realm	us
Authority	hl7
Description	Document Codes for SPL Product Submission documents
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.

Resources that use this resource

StructureDefinition
ProductSubmissionDocument	ProductSubmissionDocument

Resources that this resource uses

CodeSystem
loinc.org	Logical 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

Code	Display
98075-5	ANIMAL CELLS, TISSUES, AND CELL AND TISSUE BASED PRODUCT LABEL
77647-6	ANIMAL COMPOUNDED DRUG LABEL
104091-4	ANIMAL DRUG FOR FURTHER PROCESSING
86445-4	BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING
53409-9	BULK INGREDIENT
81203-2	BULK INGREDIENT - ANIMAL DRUG
60684-8	CELLULAR THERAPY
58474-8	COSMETIC
103573-2	COSMETIC FACILITY REGISTRATION
104087-2	COSMETIC FACILITY REGISTRATION-ABBREVIATED RENEWAL
104086-4	COSMETIC FACILITY REGISTRATION-AMENDMENT
104089-8	COSMETIC FACILITY REGISTRATION-BIENNIAL RENEWAL
104088-0	COSMETIC FACILITY REGISTRATION-CANCELLATION
103572-4	COSMETIC PRODUCT LISTING
105122-6	COSMETIC UPDATE
104090-6	COSMETIC-ABBREVIATED RENEWAL
58476-3	DIETARY SUPPLEMENT
78744-0	DRUG FOR FURTHER PROCESSING
70097-1	ESTABLISHMENT DE-REGISTRATION
51725-0	ESTABLISHMENT REGISTRATION
89600-1	FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION
99282-6	FDA-INITIATED COMPLIANCE ACTION DRUG REGISTRATION AND DRUG LISTING INACTIVATION - ANIMAL DRUG
71743-9	GENERIC DRUG FACILITY IDENTIFICATION SUBMISSION
75031-5	HUMAN COMPOUNDED DRUG LABEL
34390-5	HUMAN OTC DRUG LABEL
34391-3	HUMAN PRESCRIPTION DRUG LABEL
72090-4	IDENTIFICATION OF CBER-REGULATED GENERIC DRUG FACILITY
71446-9	INDEXING - BILLING UNIT
77648-4	INDEXING - BIOLOGICAL DRUG SUBSTANCE
93723-5	INDEXING - DRUG INTERACTIONS
63417-0	INDEXING - INDICATION
93372-1	INDEXING - NATIONAL CLINICAL TRIALS NUMBER
60685-5	INDEXING - PHARMACOLOGIC CLASS
73815-3	INDEXING - PRODUCT CONCEPT
82353-4	INDEXING - RISK EVALUATION & MITIGATION STRATEGIES
64124-1	INDEXING - SUBSTANCE
77288-9	INDEXING - WARNING LETTER ALERT
101437-2	INTENTIONAL ANIMAL GENOMIC ALTERATION LABEL
53407-3	LICENSE BLOOD INTERMEDIATES/PASTE LABEL
53408-1	LICENSED MINIMALLY MANIPULATED CELLS LABEL
53406-5	LICENSED VACCINE BULK INTERMEDIATE LABEL
66105-8	LOT DISTRIBUTION DATA
55439-4	MEDICAL DEVICE
58475-5	MEDICAL FOOD
53410-7	NO CHANGE NOTIFICATION
53405-7	NON-STANDARDIZED ALLERGENIC LABEL
69968-6	NDC LABELER CODE INACTIVATION
81204-0	NDC LABELER CODE INACTIVATION - ANIMAL DRUG
72871-7	NDC LABELER CODE REQUEST - ANIMAL DRUG
51726-8	NDC/NHRIC LABELER CODE REQUEST
50577-6	OTC ANIMAL DRUG LABEL
69403-4	OTC MEDICAL DEVICE LABEL
50576-8	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
50574-3	OTC TYPE B MEDICATED FEED ANIMAL DRUG LABEL
50573-5	OTC TYPE C MEDICATED FEED ANIMAL DRUG LABEL
53411-5	OUT OF BUSINESS NOTIFICATION
60683-0	PLASMA DERIVATIVE
50578-4	PRESCRIPTION ANIMAL DRUG LABEL
69404-2	PRESCRIPTION MEDICAL DEVICE LABEL
78745-7	RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
85274-9	REMS RELEASE
82351-8	RISK EVALUATION & MITIGATION STRATEGIES
60682-2	STANDARDIZED ALLERGENIC
53404-0	VACCINE LABEL
50575-0	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
50572-7	VFD TYPE B MEDICATED FEED ANIMAL DRUG LABEL
50571-9	VFD TYPE C MEDICATED FEED ANIMAL DRUG LABEL
75030-7	WHOLESALE DRUG DISTRIBUTORS AND THIRD-PARTY LOGISTICS FACILITY REPORT
77573-4	WITHDRAWAL 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": "2025-07-25T16:21:31+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"
          }
        ]
      }
    ]
  }
}