Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Cadila Pharmaceuticals Limited
Modavar Pharmaceuticals LLC
918451696
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nebivolol
Product Details
NDC Product Code
72241-032Application Number
ANDA208717Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 9, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 2.5 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Nebivolol
Product Details
NDC Product Code
72241-034Application Number
ANDA208717Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 9, 2023SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 10 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Nebivolol
Product Details
NDC Product Code
72241-035Application Number
ANDA208717Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 9, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 20 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
Nebivolol
Product Details
NDC Product Code
72241-033Application Number
ANDA208717Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 9, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 5 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT