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Benazepril Hydrochloride

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

Approved
Approval ID

e0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 1, 2021

Manufacturers
FDA

Amneal Pharmaceuticals of New York 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 Code53746-752
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2021
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 Code53746-753
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2021
FDA Product Classification

INGREDIENTS (1)

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

Benazepril Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53746-754
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2021
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 Code53746-751
Application NumberANDA076820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benazepril Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2021
FDA Product Classification

INGREDIENTS (1)

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

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Benazepril Hydrochloride - FDA Drug Approval Details