OZEMPIC
Initial U.S. Approval: 2017
Approved
Approval ID
e6da837c-0da0-41d6-973c-5559bf764367
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
semaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6051
Application NumberNDA209637
Product Classification
M
Marketing Category
C73594
G
Generic Name
semaglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 22, 2023
FDA Product Classification
INGREDIENTS (5)
SEMAGLUTIDEActive
Quantity: 2.68 mg in 1 mL
Code: 53AXN4NNHX
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.42 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 14.0 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
PHENOLInactive
Quantity: 5.50 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT