Fosinopril Sodium
Fosinopril Sodium Tablets, USP Rx only
Approved
Approval ID
aee04f17-8ee9-42f5-861f-b6ba17220ca4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-473
Application NumberANDA091163
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2022
FDA Product Classification
INGREDIENTS (6)
FOSINOPRIL SODIUMActive
Quantity: 40 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-472
Application NumberANDA091163
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2022
FDA Product Classification
INGREDIENTS (6)
FOSINOPRIL SODIUMActive
Quantity: 20 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-471
Application NumberANDA091163
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 8, 2022
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FOSINOPRIL SODIUMActive
Quantity: 10 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT