Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
Aurobindo Pharma Limited
918917642
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosinopril Sodium
Product Details
NDC Product Code
65862-473Application Number
ANDA091163Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 8, 2022FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 40 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
Fosinopril Sodium
Product Details
NDC Product Code
65862-472Application Number
ANDA091163Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 8, 2022FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
Fosinopril Sodium
Product Details
NDC Product Code
65862-471Application Number
ANDA091163Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 8, 2022MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FosinoprilActive
Code: NW2RTH6T2NClass: ACTIBQuantity: 10 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT