Ozempic
Initial U.S. Approval: 2017
Approved
Approval ID
fdf509ac-7ae5-49be-9a3e-8465c76f38e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2020
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 Code50090-5138
Application NumberNDA209637
Product Classification
M
Marketing Category
C73594
G
Generic Name
semaglutide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 16, 2020
FDA Product Classification
INGREDIENTS (5)
SEMAGLUTIDEActive
Quantity: 1.34 mg in 1 mL
Code: 53AXN4NNHX
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Quantity: 1.42 mg in 1 mL
Code: 94255I6E2T
Classification: IACT
PHENOLInactive
Quantity: 5.50 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 14.0 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT