FDA Structured Product Labeling (SPL)
GPTKB entity
Statements (103)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory standard
XML document standard |
| gptkbp:appliesTo |
animal drugs
biologics medical devices over-the-counter drugs prescription drugs veterinary products |
| gptkbp:basedOn |
Health Level Seven (HL7) standard
|
| gptkbp:contains |
warnings
clinical pharmacology dosage information adverse reactions contraindications product identification how supplied/storage and handling indications and usage labeling content patient counseling information structured product information |
| gptkbp:developedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:enables |
data exchange
automated processing electronic labeling public access to labeling |
| gptkbp:firstIssueDate |
2005
|
| gptkbp:format |
XML
|
| gptkbp:governedBy |
21 CFR Part 201
21 CFR Part 207 21 CFR Part 314 21 CFR Part 601 21 CFR Part 610 21 CFR Part 801 21 CFR Part 814 21 CFR Part 860 21 CFR Part 880 21 CFR Part 890 21 CFR Part 892 |
| gptkbp:hasVersion |
SPL Release 1
SPL Release 10 SPL Release 11 SPL Release 12 SPL Release 13 SPL Release 14 SPL Release 15 SPL Release 16 SPL Release 17 SPL Release 18 SPL Release 19 SPL Release 2 SPL Release 20 SPL Release 21 SPL Release 22 SPL Release 23 SPL Release 24 SPL Release 25 SPL Release 26 SPL Release 27 SPL Release 28 SPL Release 29 SPL Release 3 SPL Release 30 SPL Release 31 SPL Release 32 SPL Release 33 SPL Release 34 SPL Release 35 SPL Release 36 SPL Release 37 SPL Release 38 SPL Release 39 SPL Release 4 SPL Release 40 SPL Release 41 SPL Release 42 SPL Release 43 SPL Release 44 SPL Release 45 SPL Release 46 SPL Release 47 SPL Release 48 SPL Release 49 SPL Release 5 SPL Release 50 SPL Release 6 SPL Release 7 SPL Release 8 SPL Release 9 |
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Structured Product Labeling (SPL)
|
| gptkbp:relatedTo |
gptkb:RxNorm
gptkb:National_Library_of_Medicine gptkb:DailyMed NDC Directory Unique Ingredient Identifier (UNII) |
| gptkbp:requires |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:usedFor |
drug labeling
biologic labeling medical device labeling vaccine labeling |
| gptkbp:YouTubeChannel |
CDER Direct
Electronic Submissions Gateway (ESG) |
| gptkbp:bfsParent |
gptkb:DailyMed
|
| gptkbp:bfsLayer |
7
|