MedPath
FDA Approval

Ozempic

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
September 17, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Semaglutide(1.34 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ozempic

Product Details

NDC Product Code
50090-5138
Application Number
NDA209637
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
January 16, 2020
Code: 53AXN4NNHXClass: ACTIBQuantity: 1.34 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.42 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5.50 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 14.0 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
© Copyright 2025. All Rights Reserved by MedPath