Structured Product Labeling (SPL)
GPTKB entity
Statements (33)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
XML standard
|
| gptkbp:contains |
warnings
clinical pharmacology dosage information adverse reactions contraindications product information how supplied/storage and handling indications and usage patient counseling information |
| gptkbp:developedBy |
Health Level Seven International (HL7)
|
| gptkbp:enables |
regulatory review
electronic submission structured data exchange public access to drug information |
| gptkbp:format |
XML
|
| gptkbp:hasVersion |
SPL Release 8
|
| https://www.w3.org/2000/01/rdf-schema#label |
Structured Product Labeling (SPL)
|
| gptkbp:regulates |
biologics
medical devices over-the-counter drugs prescription drugs veterinary products |
| gptkbp:relatedTo |
gptkb:RxNorm
Unique Ingredient Identifier (UNII) National Drug Code (NDC) |
| gptkbp:standardizedBy |
gptkb:HL7
|
| gptkbp:usedBy |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:usedFor |
drug labeling
exchange of regulatory information |
| gptkbp:usedIn |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:HL7_Version_3
|
| gptkbp:bfsLayer |
6
|