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Benazepril Hydrochloride

These highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991

Approved
Approval ID

a216253b-27cb-42ef-b5a8-67fb05aafb88

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 18, 2019

Manufacturers
FDA

Amneal Pharmaceuticals LLC

DUNS: 123797875

Products 4

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

Benazepril Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65162-751
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2019
FDA Product Classification

INGREDIENTS (1)

BENAZEPRIL HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB

Benazepril Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65162-754
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2019
FDA Product Classification

INGREDIENTS (1)

BENAZEPRIL HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB

Benazepril Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65162-752
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2019
FDA Product Classification

INGREDIENTS (1)

BENAZEPRIL HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB

Benazepril Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65162-753
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2019
FDA Product Classification

INGREDIENTS (1)

BENAZEPRIL HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: N1SN99T69T
Classification: ACTIB

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Benazepril Hydrochloride - FDA Drug Approval Details