LABETALOL HYDROCHLORIDE | A200908 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7056 · 9 docket documents Hyman, Phelps & McNamara, P.C., filing on behalf of a client, submitted this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Labetalol Hydrochloride Tablets in 50 mg and 150 mg strengths suitable | Suitability | 2025-12-15 | Denied | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.2086
per ea
Lowest NADAC/Unit
$0.0843
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 49884012401LABETALOL HCL 300 MG TABLET | $0.2086 | EA | Generic | — | 2026-06-17 |
| 49884012301LABETALOL HCL 200 MG TABLET | $0.1442 | EA | Generic | — | 2026-06-17 |
| 49884012305LABETALOL HCL 200 MG TABLET | $0.1442 | EA | Generic | — | 2026-06-17 |
| 49884012201LABETALOL HCL 100 MG TABLET | $0.0843 | EA | Generic | — | 2026-06-17 |
| 49884012205LABETALOL HCL 100 MG TABLET | $0.0843 | 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.