FDA.reportPublic FDA data

Ozempic

Product NDC
50090-5139
11-digit product format
500905139
Labeler code
50090
Product ID
50090-5139_c4869820-1a83-42b5-8ba0-46fa98e373fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA209637
Marketing category
NDA
Marketing start
2017-12-06
Marketing end
0000-00-00
Substance
SEMAGLUTIDE
Active strength
1 mg/mL
Pharmacologic classes
GLP-1 Receptor Agonist [EPC],Glucagon-Like Peptide 1 [CS],Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9dd2abc7-744f-456b-a273-dec083824bd8Product name220240229
487bac84-7c5b-40cf-afd2-8b9674d4648eProduct name120220118
21318a8d-e167-4f44-9627-3daede9532ffProduct name120200227

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5139-02023-01-30C16284748780-1f386c64a-356b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OZEMPIC ® safely and effectively. See full prescribing information for OZEMPIC. OZEMPIC (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5139-0Ozempic2 in 1 CARTONINJECTION, SOLUTION21
50090-5139-0Ozempic1.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5139OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20210115_35902e95-e00c-47ae-8f4e-ba17d41881ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991317OZEMPIC 2 MG in 1.5 ML Pen Injector, 1 MG DosePSN35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991316semaglutide 2 MG in 1.5 ML Pen Injector, 1 MG DosePSN35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913171 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBD35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913161 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCD35902e95-e00c-47ae-8f4e-ba17d41881ce1
19913171 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSY35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991317OZEMPIC 2 MG per 1.5 ML Pen Injector, 1 MG DoseSY35902e95-e00c-47ae-8f4e-ba17d41881ce1
1991316semaglutide 2 MG per 1.5 ML Pen Injector, 1 MG DoseSY35902e95-e00c-47ae-8f4e-ba17d41881ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5139-0500905139002 SYRINGE, PLASTIC in 1 CARTON (50090-5139-0) > 1.5 mL in 1 SYRINGE, PLASTIC2020-08-310000-00-00NoNoCurrent