FDA.reportPublic FDA data

WEGOVY

Product NDC
50090-5824
11-digit product format
500905824
Labeler code
50090
Product ID
50090-5824_58b8887c-a572-4a74-ad0b-1049d388e206
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
semaglutide
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA215256
Marketing category
NDA
Marketing start
2021-06-05
Substance
SEMAGLUTIDE
Active strength
.25 mg/.5mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WEGOVY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEMAGLUTIDE.25 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii53AXN4NNHX
Rxcui2553501, 2553506

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
50090-5824-02023-02-07C16284748780-1f386c649-dac5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WEGOVY safely and effectively. See full prescribing information for WEGOVY. WEGOVY (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017
50090-5824-02023-01-30C16284748780-1f386c649-dac5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use WEGOVY safely and effectively. See full prescribing information for WEGOVY. WEGOVY (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5824-0WEGOVY.5 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION.56
50090-5824-0WEGOVY4 in 1 CARTONINJECTION, SOLUTION46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5824-0ML - Milliliter50090-5824b5bd0261-75f2-4e65-b47e-38f48f73706112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5824WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240425_f5e548d0-cc79-4c34-a3f5-e20a5b8b6564.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2553501semaglutide 0.25 MG in 0.5 ML Auto-InjectorPSNf5e548d0-cc79-4c34-a3f5-e20a5b8b65646
2553506wegovy 0.25 MG in 0.5 ML Auto-InjectorPSNf5e548d0-cc79-4c34-a3f5-e20a5b8b65646
25535060.5 ML semaglutide 0.5 MG/ML Auto-Injector [Wegovy]SBDf5e548d0-cc79-4c34-a3f5-e20a5b8b65646
25535010.5 ML semaglutide 0.5 MG/ML Auto-InjectorSCDf5e548d0-cc79-4c34-a3f5-e20a5b8b65646
2553501semaglutide 0.25 MG per 0.5 ML Auto-InjectorSYf5e548d0-cc79-4c34-a3f5-e20a5b8b65646
2553506Wegovy 0.25 MG per 0.5 ML Auto-InjectorSYf5e548d0-cc79-4c34-a3f5-e20a5b8b65646

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5824-0500905824004 SYRINGE, PLASTIC in 1 CARTON (50090-5824-0) / .5 mL in 1 SYRINGE, PLASTIC2021-10-250000-00-00NoNoCurrent