HYDROCHLOROTHIAZIDE | A083177 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research International, LLC FDA-2025-P-7285 Premier Research International, LLC filed this ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that Hydrochlorothiazide Oral Suspension is suitable for submission as an Abbreviated New Drug Application, with the proposed su | Suitability | 2025-12-22 | Open | Premier Research International, LLC |
Suitability Petition from Premier Consulting FDA-2024-P-4956 Premier Consulting filed this ANDA Suitability Petition on October 23, 2024, requesting FDA confirmation that Hydrochlorothiazide Oral Liquid is suitable for submission as an Abbreviated New Drug Application pursuant to section 505(j)(2)(C) of the FD&C Act. The petition proposes to develop a 50 mg p | Suitability | 2024-10-24 | Granted | Premier Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0358
per ea
Lowest NADAC/Unit
$0.0114
per ea
Brand NDCs
0
Generic NDCs
7
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00172344480HYDROCHLOROTHIAZIDE 12.5 MG TB | $0.0358 | EA | Generic | — | 2026-10-21 |
| 00172344460HYDROCHLOROTHIAZIDE 12.5 MG TB | $0.0358 | EA | Generic | — | 2026-10-21 |
| 00172208980HYDROCHLOROTHIAZIDE 50 MG TAB | $0.0312 | EA | Generic | — | 2026-10-21 |
| 00172208960HYDROCHLOROTHIAZIDE 50 MG TAB | $0.0312 | EA | Generic | — | 2026-10-21 |
| 00172208360HYDROCHLOROTHIAZIDE 25 MG TAB | $0.0114 | EA | Generic | — | 2026-10-21 |
| 00172208380HYDROCHLOROTHIAZIDE 25 MG TAB | $0.0114 | EA | Generic | — | 2026-10-21 |
| 68645051054HYDROCHLOROTHIAZIDE 25 MG TAB | $0.0114 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.