SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - 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 0.2.1 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/splSectionCodes | Version: 0.2.1 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SPLSectionCodes | ||
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. |
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Section Codes for SPL Product Submission documents
References
Generated Narrative: ValueSet splSectionCodes
http://loinc.org| Code | Display |
| 34086-9 | ABUSE SECTION |
| 60555-0 | ACCESSORIES |
| 34084-4 | ADVERSE REACTIONS SECTION |
| 69761-5 | ALARMS |
| 34091-9 | ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION |
| 60556-8 | ASSEMBLY OR INSTALLATION INSTRUCTIONS |
| 34066-1 | BOXED WARNING SECTION |
| 60557-6 | CALIBRATION INSTRUCTIONS |
| 34083-6 | CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION |
| 34090-1 | CLINICAL PHARMACOLOGY SECTION |
| 60558-4 | CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS |
| 34092-7 | CLINICAL STUDIES SECTION |
| 90374-0 | CLINICAL TRIALS EXPERIENCE SECTION |
| 69760-7 | COMPATIBLE ACCESSORIES |
| 60559-2 | COMPONENTS |
| 34070-3 | CONTRAINDICATIONS SECTION |
| 34085-1 | CONTROLLED SUBSTANCE SECTION |
| 34087-7 | DEPENDENCE SECTION |
| 34089-3 | DESCRIPTION SECTION |
| 69758-1 | DIAGRAM OF DEVICE |
| 69763-1 | DISPOSAL AND WASTE HANDLING |
| 34068-7 | DOSAGE & ADMINISTRATION SECTION |
| 43678-2 | DOSAGE FORMS & STRENGTHS SECTION |
| 34074-5 | DRUG & OR LABORATORY TEST INTERACTIONS SECTION |
| 42227-9 | DRUG ABUSE AND DEPENDENCE SECTION |
| 34073-7 | DRUG INTERACTIONS SECTION |
| 50742-6 | ENVIRONMENTAL WARNING SECTION |
| 77291-3 | FEMALES & MALES OF REPRODUCTIVE POTENTIAL SECTION |
| 50743-4 | FOOD SAFETY WARNING SECTION |
| 34072-9 | GENERAL PRECAUTIONS SECTION |
| 34082-8 | GERIATRIC USE SECTION |
| 50740-0 | GUARANTEED ANALYSIS OF FEED SECTION |
| 71744-7 | HEALTH CARE PROVIDER LETTER SECTION |
| 69719-3 | HEALTH CLAIM SECTION |
| 88829-7 | HEPATIC IMPAIRMENT SUBSECTION |
| 34069-5 | HOW SUPPLIED SECTION |
| 88830-5 | IMMUNOGENICITY |
| 51727-6 | INACTIVE INGREDIENT SECTION |
| 34067-9 | INDICATIONS & USAGE SECTION |
| 50744-2 | INFORMATION FOR OWNERS/CAREGIVERS SECTION |
| 34076-0 | INFORMATION FOR PATIENTS SECTION |
| 59845-8 | INSTRUCTIONS FOR USE SECTION |
| 60560-0 | INTENDED USE OF THE DEVICE |
| 34079-4 | LABOR & DELIVERY SECTION |
| 34075-2 | LABORATORY TESTS SECTION |
| 77290-5 | LACTATION SECTION |
| 43679-0 | MECHANISM OF ACTION SECTION |
| 49489-8 | MICROBIOLOGY SECTION |
| 43680-8 | NONCLINICAL TOXICOLOGY SECTION |
| 34078-6 | NONTERATOGENIC EFFECTS SECTION |
| 34080-2 | NURSING MOTHERS SECTION |
| 60561-8 | OTHER SAFETY INFORMATION |
| 34088-5 | OVERDOSAGE SECTION |
| 55106-9 | OTC - ACTIVE INGREDIENT SECTION |
| 50569-3 | OTC - ASK DOCTOR SECTION |
| 50568-5 | OTC - ASK DOCTOR/PHARMACIST SECTION |
| 50570-1 | OTC - DO NOT USE SECTION |
| 50565-1 | OTC - KEEP OUT OF REACH OF CHILDREN SECTION |
| 53414-9 | OTC - PREGNANCY OR BREAST FEEDING SECTION |
| 55105-1 | OTC - PURPOSE SECTION |
| 53413-1 | OTC - QUESTIONS SECTION |
| 50566-9 | OTC - STOP USE SECTION |
| 50567-7 | OTC - WHEN USING SECTION |
| 51945-4 | PACKAGE LABEL.PRINCIPAL DISPLAY PANEL |
| 88436-1 | PATIENT COUNSELING INFORMATION |
| 68498-5 | PATIENT MEDICATION INFORMATION SECTION |
| 34081-0 | PEDIATRIC USE SECTION |
| 43681-6 | PHARMACODYNAMICS SECTION |
| 66106-6 | PHARMACOGENOMICS SECTION |
| 43682-4 | PHARMACOKINETICS SECTION |
| 90375-7 | POSTMARKETING EXPERIENCE SECTION |
| 42232-9 | PRECAUTIONS SECTION |
| 42228-7 | PREGNANCY SECTION |
| 43683-2 | RECENT MAJOR CHANGES SECTION |
| 34093-5 | REFERENCES SECTION |
| 53412-3 | RESIDUE WARNING SECTION |
| 100382-1 | REMS ADDRESSED RISK |
| 87523-7 | REMS ADMINISTRATIVE INFORMATION |
| 87526-0 | REMS APPLICANT REQUIREMENTS |
| 82344-3 | REMS COMMUNICATION |
| 82348-4 | REMS ELEMENTS |
| 82345-0 | REMS ELEMENTS TO ASSURE SAFE USE |
| 82349-2 | REMS GOALS |
| 82350-0 | REMS IMPLEMENTATION SYSTEM |
| 82346-8 | REMS MATERIAL |
| 82598-4 | REMS MEDICATION GUIDE |
| 87525-2 | REMS PARTICIPANT REQUIREMENTS |
| 87524-5 | REMS REQUIREMENTS |
| 82347-6 | REMS SUMMARY |
| 82352-6 | REMS TIMETABLE FOR SUBMISSION ASSESSMENTS |
| 88828-9 | RENAL IMPAIRMENT SUBSECTION |
| 69759-9 | RISKS |
| 60562-6 | ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION |
| 50741-8 | SAFE HANDLING WARNING SECTION |
| 48779-3 | SPL INDEXING DATA ELEMENTS SECTION |
| 48780-1 | SPL PRODUCT DATA ELEMENTS SECTION |
| 42231-1 | SPL MEDGUIDE SECTION |
| 42230-3 | SPL PATIENT PACKAGE INSERT SECTION |
| 42229-5 | SPL UNCLASSIFIED SECTION |
| 69718-5 | STATEMENT OF IDENTITY SECTION |
| 44425-7 | STORAGE AND HANDLING SECTION |
| 60563-4 | SUMMARY OF SAFETY AND EFFECTIVENESS |
| 34077-8 | TERATOGENIC EFFECTS SECTION |
| 69762-3 | TROUBLESHOOTING |
| 43684-0 | USE IN SPECIFIC POPULATIONS SECTION |
| 54433-8 | USER SAFETY WARNINGS SECTION |
| 50745-9 | VETERINARY INDICATIONS SECTION |
| 43685-7 | WARNINGS AND PRECAUTIONS SECTION |
| 34071-1 | WARNINGS SECTION |
Generated Narrative: ValueSet
Expansion based on Loinc v2.78
This value set contains 109 concepts
| Code | System | Display |
| 34086-9 | http://loinc.org | FDA package insert Abuse section |
| 60555-0 | http://loinc.org | FDA package insert Accessories |
| 34084-4 | http://loinc.org | FDA package insert Adverse reactions section |
| 69761-5 | http://loinc.org | FDA package insert Alarms |
| 34091-9 | http://loinc.org | FDA package insert Animal pharmacology/toxicology section |
| 60556-8 | http://loinc.org | FDA package insert Assembly or installation instructions |
| 34066-1 | http://loinc.org | FDA package insert Boxed warning section |
| 60557-6 | http://loinc.org | FDA package insert Calibration instructions |
| 34083-6 | http://loinc.org | FDA package insert Carcinogenesis and mutagenesis and impairment of fertility section |
| 34090-1 | http://loinc.org | FDA package insert Clinical pharmacology section |
| 60558-4 | http://loinc.org | FDA package insert Cleaning, disinfecting, and sterilization instructions |
| 34092-7 | http://loinc.org | FDA package insert Clinical studies section |
| 90374-0 | http://loinc.org | FDA package insert Clinical trials experience section |
| 69760-7 | http://loinc.org | FDA package insert Compatible accessories |
| 60559-2 | http://loinc.org | FDA package insert Components |
| 34070-3 | http://loinc.org | FDA package insert Contraindications section |
| 34085-1 | http://loinc.org | FDA package insert Controlled substance section |
| 34087-7 | http://loinc.org | FDA package insert Dependence section |
| 34089-3 | http://loinc.org | FDA package insert Description section |
| 69758-1 | http://loinc.org | FDA package insert Diagram of device |
| 69763-1 | http://loinc.org | FDA package insert Disposal and waste handling |
| 34068-7 | http://loinc.org | FDA package insert Dosage and administration section |
| 43678-2 | http://loinc.org | FDA package insert Dosage forms and strengths section |
| 34074-5 | http://loinc.org | FDA package insert Drug/laboratory test interactions section |
| 42227-9 | http://loinc.org | FDA package insert Drug abuse and dependence section |
| 34073-7 | http://loinc.org | FDA package insert Drug interactions section |
| 50742-6 | http://loinc.org | FDA product label Environmental warning section |
| 77291-3 | http://loinc.org | FDA package insert Females and males reproductive potential |
| 50743-4 | http://loinc.org | FDA product label Food safety warning section |
| 34072-9 | http://loinc.org | FDA package insert General precautions section |
| 34082-8 | http://loinc.org | FDA package insert Geriatric use section |
| 50740-0 | http://loinc.org | FDA product label Guaranteed analysis of feed section |
| 71744-7 | http://loinc.org | FDA package insert Health care provider letter |
| 69719-3 | http://loinc.org | FDA product label Health claim section |
| 88829-7 | http://loinc.org | FDA package insert Hepatic Impairment subsection |
| 34069-5 | http://loinc.org | FDA package insert How supplied section |
| 88830-5 | http://loinc.org | FDA package insert Immunogenicity |
| 51727-6 | http://loinc.org | FDA product label Inactive ingredient section |
| 34067-9 | http://loinc.org | FDA package insert Indications and usage section |
| 50744-2 | http://loinc.org | FDA product label Information for owners or caregivers section |
| 34076-0 | http://loinc.org | FDA package insert Information for patients section |
| 59845-8 | http://loinc.org | FDA package insert Instructions for use section |
| 60560-0 | http://loinc.org | FDA package insert Intended use of the device |
| 34079-4 | http://loinc.org | FDA package insert Labor and delivery section |
| 34075-2 | http://loinc.org | FDA package insert Laboratory tests section |
| 77290-5 | http://loinc.org | FDA package insert Lactation |
| 43679-0 | http://loinc.org | FDA package insert Mechanism of action section |
| 49489-8 | http://loinc.org | FDA package insert Microbiology section |
| 43680-8 | http://loinc.org | FDA package insert Nonclinical toxicology section |
| 34078-6 | http://loinc.org | FDA package insert Nonteratogenic effects section |
| 34080-2 | http://loinc.org | FDA package insert Nursing mothers section |
| 60561-8 | http://loinc.org | FDA package insert Other safety information |
| 34088-5 | http://loinc.org | FDA package insert Overdosage section |
| 55106-9 | http://loinc.org | FDA product label OTC - Active ingredient section |
| 50569-3 | http://loinc.org | FDA product label OTC - Ask doctor section |
| 50568-5 | http://loinc.org | FDA product label OTC - Ask doctor or pharmacist section |
| 50570-1 | http://loinc.org | FDA product label OTC - Do not use section |
| 50565-1 | http://loinc.org | FDA product label OTC - Keep out of reach of children section |
| 53414-9 | http://loinc.org | FDA product label OTC - Pregnancy or breast feeding section |
| 55105-1 | http://loinc.org | FDA product label OTC - Purpose section |
| 53413-1 | http://loinc.org | FDA product label OTC - Questions section |
| 50566-9 | http://loinc.org | FDA product label OTC - Stop use section |
| 50567-7 | http://loinc.org | FDA product label OTC - When using section |
| 51945-4 | http://loinc.org | FDA product label Principal display panel of package |
| 88436-1 | http://loinc.org | FDA package insert Patient counseling information |
| 68498-5 | http://loinc.org | FDA product label Patient medication information section |
| 34081-0 | http://loinc.org | FDA package insert Pediatric use section |
| 43681-6 | http://loinc.org | FDA package insert Pharmacodynamics section |
| 66106-6 | http://loinc.org | FDA package insert Pharmacogenomics section |
| 43682-4 | http://loinc.org | FDA package insert Pharmacokinetics section |
| 90375-7 | http://loinc.org | FDA package insert Postmarketing experience section |
| 42232-9 | http://loinc.org | FDA package insert Precautions section |
| 42228-7 | http://loinc.org | FDA package insert Pregnancy section |
| 43683-2 | http://loinc.org | FDA package insert Recent major changes section |
| 34093-5 | http://loinc.org | FDA package insert References section |
| 53412-3 | http://loinc.org | FDA product label Residue warning section |
| 100382-1 | http://loinc.org | FDA package insert REMS addressed risk |
| 87523-7 | http://loinc.org | FDA package insert REMS administrative information |
| 87526-0 | http://loinc.org | FDA package insert REMS applicant requirements |
| 82344-3 | http://loinc.org | FDA package insert REMS communication plan |
| 82348-4 | http://loinc.org | FDA package insert REMS elements |
| 82345-0 | http://loinc.org | FDA package insert REMS elements to assure safe use |
| 82349-2 | http://loinc.org | FDA package insert REMS goals |
| 82350-0 | http://loinc.org | FDA package insert REMS implementation system |
| 82346-8 | http://loinc.org | FDA package insert REMS material |
| 82598-4 | http://loinc.org | FDA package insert REMS medication guide |
| 87525-2 | http://loinc.org | FDA package insert REMS participant requirements |
| 87524-5 | http://loinc.org | FDA package insert REMS requirements |
| 82347-6 | http://loinc.org | FDA package insert REMS summary |
| 82352-6 | http://loinc.org | FDA package insert REMS timetable for submission assessments |
| 88828-9 | http://loinc.org | FDA package insert Renal Impairment subsection |
| 69759-9 | http://loinc.org | FDA package insert Risks |
| 60562-6 | http://loinc.org | FDA package insert Route, method and frequency of administration |
| 50741-8 | http://loinc.org | FDA product label Safe handling warning section |
| 48779-3 | http://loinc.org | FDA package insert Structured product labelling indexing data elements section |
| 48780-1 | http://loinc.org | FDA package insert Structured product labelling listing data elements section |
| 42231-1 | http://loinc.org | FDA package insert Structured product labelling medguide section |
| 42230-3 | http://loinc.org | FDA package insert Structured product laballing patient package insert section |
| 42229-5 | http://loinc.org | FDA package insert Structured patient labelling unclassified section |
| 69718-5 | http://loinc.org | FDA product label Statement of identity section |
| 44425-7 | http://loinc.org | FDA package insert Storage and handling section |
| 60563-4 | http://loinc.org | FDA package insert Summary of safety and effectiveness |
| 34077-8 | http://loinc.org | FDA package insert Teratogenic effects section |
| 69762-3 | http://loinc.org | FDA package insert Troubleshooting |
| 43684-0 | http://loinc.org | FDA package insert Use in specific populations section |
| 54433-8 | http://loinc.org | FDA package insert User safety warnings section |
| 50745-9 | http://loinc.org | FDA product label Veterinary indications section |
| 43685-7 | http://loinc.org | FDA package insert Warnings and precautions section |
| 34071-1 | http://loinc.org | FDA package insert Warnings section |
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#0.2.1 based on FHIR 5.0.0. Generated 2024-12-10
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