FDA.reportPublic FDA data

Ozempic

Product NDC
50090-5138
11-digit product format
500905138
Labeler code
50090
Product ID
50090-5138_ef30340f-e1f2-4ee5-af80-1cb6ac71ec3c
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
2021-12-31
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
50090-5138-02023-01-30C16284748780-1f386c64a-4523-0266-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
50090-5138-0Ozempic1 in 1 CARTONINJECTION, SOLUTION11
50090-5138-0Ozempic1.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION1.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5138OZEMPIC (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20200918_fdf509ac-7ae5-49be-9a3e-8465c76f38e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1991311OZEMPIC 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG DosePSNfdf509ac-7ae5-49be-9a3e-8465c76f38e11
1991306semaglutide 2 MG in 1.5 ML Pen Injector, 0.25 or 0.5 MG DosePSNfdf509ac-7ae5-49be-9a3e-8465c76f38e11
19913110.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen Injector [Ozempic]SBDfdf509ac-7ae5-49be-9a3e-8465c76f38e11
19913060.25 MG, 0.5 MG Dose 1.5 ML semaglutide 1.34 MG/ML Pen InjectorSCDfdf509ac-7ae5-49be-9a3e-8465c76f38e11
19913110.25 MG, 0.5 MG Dose 1.5 ML Ozempic 1.34 MG/ML Pen InjectorSYfdf509ac-7ae5-49be-9a3e-8465c76f38e11
1991311OZEMPIC 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG DoseSYfdf509ac-7ae5-49be-9a3e-8465c76f38e11
1991306semaglutide 2 MG per 1.5 ML Pen Injector, 0.25 or 0.5 MG DoseSYfdf509ac-7ae5-49be-9a3e-8465c76f38e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5138-0500905138001 SYRINGE, PLASTIC in 1 CARTON (50090-5138-0) > 1.5 mL in 1 SYRINGE, PLASTIC2020-08-280000-00-00NoNoCurrent