Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novo Nordisk Pharmaceutical Industries, LP
Novo Nordisk
622920320
Novo Nordisk A/S
Novo Nordisk
305914798
Products5
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
0169-4130Application Number
NDA209637Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
September 22, 2023PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 14.0 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5.50 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SemaglutideActive
Code: 53AXN4NNHXClass: ACTIBQuantity: 1.34 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.42 mg in 1 mL
Ozempic
Product Details
NDC Product Code
0169-4772Application Number
NDA209637Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
September 22, 2023SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.42 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5.50 mg in 1 mL
SemaglutideActive
Code: 53AXN4NNHXClass: ACTIBQuantity: 2.68 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 14.0 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Ozempic
Product Details
NDC Product Code
0169-4181Application Number
NDA209637Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
September 22, 2023SemaglutideActive
Code: 53AXN4NNHXClass: ACTIBQuantity: 0.68 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.42 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 14.0 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5.50 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Ozempic
Product Details
NDC Product Code
0169-4132Application Number
NDA209637Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
September 22, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 1.42 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 14.0 mg in 1 mL
PHENOLInactive
Code: 339NCG44TVClass: IACTQuantity: 5.50 mg in 1 mL
SemaglutideActive
Code: 53AXN4NNHXClass: ACTIBQuantity: 1.34 mg in 1 mL
Ozempic
Product Details
NDC Product Code
0169-4136Application Number
NDA209637Marketing Category
NDA (C73594)Route of Administration
SUBCUTANEOUSEffective Date
September 22, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
SemaglutideActive
Code: 53AXN4NNHXClass: ACTIBQuantity: 1.34 mg in 1 mL
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACTQuantity: 14.0 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