NALTREXONE HYDROCHLORIDE | A076264 | SPECGX LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5194 · 7 docket documents Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed this Suitability Petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that FDA declare Naltrexone Hydrochloride Oral Suspension, 5 mg/mL, suitable for submission as an A | Suitability | 2026-05-11 | Open | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.19
per ea
Lowest NADAC/Unit
$1.19
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00406117001NALTREXONE 50 MG TABLET | $1.19 | EA | Generic | — | 2026-06-17 |
| 00406117003NALTREXONE 50 MG TABLET | $1.19 | EA | Generic | — | 2026-06-17 |
| 68084029121NALTREXONE 50 MG TABLET | $1.19 | 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.