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FDA Approval

Moexipril Hydrochloride

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

FDA Approval Summary

Company
Effective Date
April 14, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Moexipril(7.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Moexipril Hydrochloride

Product Details

NDC Product Code
54868-5928
Application Number
ANDA078454
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 14, 2011
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MoexiprilActive
Code: Q1UMG3UH45Class: ACTIBQuantity: 7.5 mg in 1 1
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT

Moexipril Hydrochloride

Product Details

NDC Product Code
54868-4883
Application Number
ANDA078454
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 14, 2011
MoexiprilActive
Code: Q1UMG3UH45Class: ACTIBQuantity: 15 mg in 1 1
MAGNESIUM CARBONATEInactive
Code: 0E53J927NAClass: IACT
ZINC STEARATEInactive
Code: H92E6QA4FVClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
COPOVIDONEInactive
Code: D9C330MD8BClass: IACT
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