SPL Mapping FHIR R5 Implementation Guide
0.2.8 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.8 - Build CI
SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.8 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/spl/ValueSet/splDocumentCodes | Version: 0.2.8 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SPLDocumentCodes | ||
Copyright/Legal: 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. |
||||
Document Codes for SPL Product Submission documents
References
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 |
Expansion from tx.fhir.org based on Loinc v2.80
This value set contains 69 concepts
| Code | System | Display (en-US) |
| 98075-5 | http://loinc.org | FDA product label Animal cells, tissues, and cell and tissue based product label |
| 77647-6 | http://loinc.org | FDA product label Animal compounded drug label |
| 104091-4 | http://loinc.org | FDA product label Animal drug for further processing |
| 86445-4 | http://loinc.org | FDA package insert Blanket no changes certification of product listing |
| 53409-9 | http://loinc.org | FDA product label Bulk ingredient |
| 81203-2 | http://loinc.org | FDA product label Bulk ingredient - animal drug |
| 60684-8 | http://loinc.org | FDA product label Cellular therapy |
| 58474-8 | http://loinc.org | FDA product label Cosmetic |
| 103573-2 | http://loinc.org | FDA package insert Cosmetic facility registration |
| 104087-2 | http://loinc.org | FDA product label Cosmetic facility registration-abbreviated renewal |
| 104086-4 | http://loinc.org | FDA product label Cosmetic facility registration-amendment |
| 104089-8 | http://loinc.org | FDA product label Cosmetic facility registration-biennial renewal |
| 104088-0 | http://loinc.org | FDA product label Cosmetic facility registration-cancellation |
| 103572-4 | http://loinc.org | FDA package insert Cosmetic product listing |
| 105122-6 | http://loinc.org | FDA product label Cosmetic update |
| 104090-6 | http://loinc.org | FDA product label Cosmetic-abbreviated renewal |
| 58476-3 | http://loinc.org | FDA product label Dietary supplement |
| 78744-0 | http://loinc.org | FDA product label Drug for further processing label |
| 70097-1 | http://loinc.org | FDA product label Establishment de-registration |
| 51725-0 | http://loinc.org | FDA product label Establishment registration |
| 89600-1 | http://loinc.org | FDA product label FDA-initiated compliance action drug registration and listing inactivation |
| 99282-6 | http://loinc.org | FDA product label FDA-initiated compliance action drug registration and listing inactivation - animal drug |
| 71743-9 | http://loinc.org | FDA product label Generic drug facility identification submission |
| 75031-5 | http://loinc.org | FDA product label Human compounded drug label |
| 34390-5 | http://loinc.org | FDA product label Human OTC drug label |
| 34391-3 | http://loinc.org | FDA product label Human prescription drug label |
| 72090-4 | http://loinc.org | FDA product label Identification of CBER-regulated generic drug facility |
| 71446-9 | http://loinc.org | FDA package insert Indexing - billing unit |
| 77648-4 | http://loinc.org | FDA product label Indexing - biologic or drug substance |
| 93723-5 | http://loinc.org | FDA product label Indexing - drug interactions |
| 63417-0 | http://loinc.org | FDA product label Indexing - Indication |
| 93372-1 | http://loinc.org | FDA product label Indexing - national clinical trial number |
| 60685-5 | http://loinc.org | FDA package insert Indexing - pharmacologic class |
| 73815-3 | http://loinc.org | FDA package insert Indexing - product concept |
| 82353-4 | http://loinc.org | FDA package insert Indexing - risk evaluation and mitigation strategies |
| 64124-1 | http://loinc.org | FDA package insert Indexing - substance |
| 77288-9 | http://loinc.org | FDA package insert Indexing - warning letter alert |
| 101437-2 | http://loinc.org | FDA product label Intentional animal genomic alteration label |
| 53407-3 | http://loinc.org | FDA product label Licensed blood intermediate/paste label |
| 53408-1 | http://loinc.org | FDA product label Licensed minimally manipulated cells label |
| 53406-5 | http://loinc.org | FDA product label Licensed vaccine bulk intermediate label |
| 66105-8 | http://loinc.org | FDA package insert Lot distribution data |
| 55439-4 | http://loinc.org | FDA product label Medical device |
| 58475-5 | http://loinc.org | FDA product label Medical food |
| 53410-7 | http://loinc.org | FDA product label No change notification |
| 53405-7 | http://loinc.org | FDA product label Non-standardized allergenic label |
| 69968-6 | http://loinc.org | FDA product label NDC labeler code inactivation |
| 81204-0 | http://loinc.org | FDA product label NDC labeler code inactivation - animal drug |
| 72871-7 | http://loinc.org | FDA product label NDC labeler code request - animal drug |
| 51726-8 | http://loinc.org | FDA product label NDC labeler code request |
| 50577-6 | http://loinc.org | FDA product label OTC animal drug label |
| 69403-4 | http://loinc.org | FDA product label OTC medical device label |
| 50576-8 | http://loinc.org | FDA product label OTC Type A medicated article animal drug label |
| 50574-3 | http://loinc.org | FDA product label OTC Type B medicated feed animal drug label |
| 50573-5 | http://loinc.org | FDA product label OTC Type C medicated feed animal drug label |
| 53411-5 | http://loinc.org | FDA product label Out of business notification |
| 60683-0 | http://loinc.org | FDA product label Plasma derivative |
| 50578-4 | http://loinc.org | FDA product label Prescription animal drug label |
| 69404-2 | http://loinc.org | FDA product label Prescription medical device label |
| 78745-7 | http://loinc.org | FDA product label Recombinant deoxyribonucleic acid construct label |
| 85274-9 | http://loinc.org | FDA package insert REMS release |
| 82351-8 | http://loinc.org | FDA package insert Risk evaluation and mitigation strategies |
| 60682-2 | http://loinc.org | FDA product label Standardized allergenic |
| 53404-0 | http://loinc.org | FDA product label Vaccine label |
| 50575-0 | http://loinc.org | FDA product label VFD Type A medicated article animal drug label |
| 50572-7 | http://loinc.org | FDA product label VFD Type B medicated feed animal drug label |
| 50571-9 | http://loinc.org | FDA product label VFD Type C medicated feed animal drug label |
| 75030-7 | http://loinc.org | FDA product label Wholesale drug distributors and third-party logistics facility registration |
| 77573-4 | http://loinc.org | FDA product label Withdrawal of wholesale drug distributors and third-party logistics facility report |
Explanation of the columns that may appear on this page:
| Level | A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies |
| System | The source of the definition of the code (when the value set draws in codes defined elsewhere) |
| Code | The code (used as the code in the resource instance) |
| Display | The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application |
| Definition | An explanation of the meaning of the concept |
| Comments | Additional notes about how to use the code |
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.8 based on FHIR 5.0.0. Generated 2025-07-25
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change