MedPath
FDA Approval

Fosinopril Sodium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Chartwell RX, LLC
DUNS: 079394054
Effective Date
June 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fosinopril(20 mg in 1 1)

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
62135-042
Application Number
ANDA076483
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 6, 2023
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
Code: NW2RTH6T2NClass: ACTIBQuantity: 20 mg in 1 1

Fosinopril Sodium

Product Details

NDC Product Code
62135-043
Application Number
ANDA076483
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 6, 2023
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: NW2RTH6T2NClass: ACTIBQuantity: 40 mg in 1 1

Fosinopril Sodium

Product Details

NDC Product Code
62135-041
Application Number
ANDA076483
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 6, 2023
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
Code: NW2RTH6T2NClass: ACTIBQuantity: 10 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath