BENAZEPRIL HYDROCHLORIDE | A076118 | PRINSTON PHARMACEUTICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-4955 · 9 docket documents Premier Consulting filed an amendment to its ANDA suitability petition (FDA-2024-P-4955) for Benazepril Hydrochloride Oral Liquid, clarifying that the proposed dosage form will be a liquid formulation—either a solution, suspension, or powder for suspension—intended for oral administration, in respon | Suitability | 2024-11-13 | Denied | Premier Consulting |
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-3571 · 9 docket documents Premier Consulting filed this petition seeking permission to file an ANDA for Amoxicillin and Benazepril Hydrochloride Oral Liquid, and requesting that the FDA determine that "liquid" is an acceptable dosage form for these drugs under 21 CFR 314.94(a)(5). | Suitability | 2024-11-13 | Granted | Premier Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0967
per ea
Lowest NADAC/Unit
$0.0482
per ea
Brand NDCs
0
Generic NDCs
9
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 43547033850BENAZEPRIL HCL 40 MG TABLET | $0.0967 | EA | Generic | — | 2026-06-17 |
| 43547033803BENAZEPRIL HCL 40 MG TABLET | $0.0967 | EA | Generic | — | 2026-06-17 |
| 43547033810BENAZEPRIL HCL 40 MG TABLET | $0.0967 | EA | Generic | — | 2026-06-17 |
| 43547033710BENAZEPRIL HCL 20 MG TABLET | $0.0765 | EA | Generic | — | 2026-06-17 |
| 43547033703BENAZEPRIL HCL 20 MG TABLET | $0.0765 | EA | Generic | — | 2026-06-17 |
| 43547033750BENAZEPRIL HCL 20 MG TABLET | $0.0765 | EA | Generic | — | 2026-06-17 |
Showing 6 of 9 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.