BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | N020033 | VALIDUS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research International, LLC FDA-2025-P-7284 · 4 docket documents Premier Research International, LLC filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93, requesting FDA confirmation that Benazepril Hydrochloride and Hydrochlorothiazide Powder for Oral Suspension is suitable for ANDA s | Suitability | 2025-12-22 | Granted | Premier Research International, LLC |
Suitability Petition from Premier Consulting FDA-2024-P-4954 · 9 docket documents Premier Consulting filed this ANDA suitability petition in October 2024 requesting FDA confirmation that benazepril hydrochloride and hydrochlorothiazide oral liquid is suitable for submission as an abbreviated new drug application under section 505(j)(2)(C). The petitioner also seeks a full waiver | Suitability | 2024-10-24 | Granted | Premier Consulting |
Citizen Petition from EAS Consulting Group ( Jubilant Generics Ltd.) FDA-2017-P-4852 · 4 docket documents Jubilant Generics Ltd., through EAS Consulting Group, filed this petition pursuant to 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine the discontinuation of the 5 mg/6.25 mg strength of LOTENSIN HCT (Benazepril Hydrochloride and Hydrochlorothiazide, NDA N02003 | Other | 2017-08-11 | Granted | EAS Consulting Group ( Jubilant Generics Ltd.) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.2521
per ea
Lowest NADAC/Unit
$0.1753
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72888022001BENAZEPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | $0.2521 | EA | Generic | — | 2026-06-17 |
| 72888022201BENAZEPRIL-HYDROCHLOROTHIAZIDE 20-25 MG TAB | $0.2378 | EA | Generic | — | 2026-06-17 |
| 00574022801BENAZEPRIL-HYDROCHLOROTHIAZIDE 20-25 MG TAB | $0.2378 | EA | Generic | — | 2026-06-17 |
| 72888022101BENAZEPRIL-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB | $0.1753 | EA | Generic | — | 2026-06-17 |
| 00574022901BENAZEPRIL-HYDROCHLOROTHIAZIDE 20-12.5 MG TAB | $0.1753 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.