FDA Orange Book · active-ingredient family
Benazepril hydrochloride
Benazepril hydrochloride: 1 brand, 12 generics; first approved Jun 25, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
12
Listed patents
0
Presentations
51
Brand (NDA) products
Originator applications
- LOTENSINRLDVALIDUS PHARMSNDA 01985119914 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB
Generic (ANDA) products (12)
Abbreviated applications
- BENAZEPRIL HYDROCHLORIDEZYDUS LIFESCIENCESANDA 07884820084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMAANDA 07821220083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDECOREPHARMAANDA 07712820064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDEAMNEAL PHARMSANDA 07682020064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDEANI PHARMSANDA 07633320044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDECHARTWELL RXANDA 07640220044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDEGENPHARMANDA 07647620044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - BENAZEPRIL HYDROCHLORIDEHERITAGE PHARMAANDA 07626720044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDEPRINSTON INCANDA 07611820044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDERISINGANDA 07643020044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - BENAZEPRIL HYDROCHLORIDESUN PHARM INDS LTDANDA 07634420044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - BENAZEPRIL HYDROCHLORIDETEVAANDA 07621120044 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
35 yr 7 mo ago
Most recent approval
18 yr 5 mo ago
Approvals span 1991–2008 across 13 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1292%
Benazepril hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
