Fosinopril Sodium
Fosinopril Sodium Tablets, USP R only
Approved
Approval ID
ff1323cc-7ad8-488d-94a7-a11555db78a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-042
Application NumberANDA076483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (6)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FOSINOPRIL SODIUMActive
Quantity: 20 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-043
Application NumberANDA076483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (6)
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FOSINOPRIL SODIUMActive
Quantity: 40 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB
Fosinopril Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-041
Application NumberANDA076483
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosinopril Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 6, 2023
FDA Product Classification
INGREDIENTS (6)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZINC STEARATEInactive
Code: H92E6QA4FV
Classification: IACT
FOSINOPRIL SODIUMActive
Quantity: 10 mg in 1 1
Code: NW2RTH6T2N
Classification: ACTIB