Ozempic
Initial U.S. Approval: 2017
Approved
Approval ID
adec4fd2-6858-4c99-91d4-531f5f2a2d79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2023
Manufacturers
FDA
Novo Nordisk
DUNS: 622920320
Products 5
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 Code0169-4130
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)
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
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
semaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-4772
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)
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
SEMAGLUTIDEActive
Quantity: 2.68 mg in 1 mL
Code: 53AXN4NNHX
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 14.0 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
semaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-4181
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: 0.68 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
semaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-4132
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)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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
SEMAGLUTIDEActive
Quantity: 1.34 mg in 1 mL
Code: 53AXN4NNHX
Classification: ACTIB
semaglutide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0169-4136
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)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SEMAGLUTIDEActive
Quantity: 1.34 mg in 1 mL
Code: 53AXN4NNHX
Classification: ACTIB
PROPYLENE GLYCOLInactive
Quantity: 14.0 mg in 1 mL
Code: 6DC9Q167V3
Classification: IACT
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