HYDROCORTISONE | A081271 | MISSION PHARMACAL CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Epstein Becker Green FDA-2025-P-1070 · 8 docket documents Epstein Becker & Green, P.C., filed this suitability petition under Federal Food, Drug, and Cosmetic Act Section 505(j)(2)(C) requesting that the FDA determine hydrocortisone topical gel 2.5% suitable for submission as an Abbreviated New Drug Application, with the listed drug being Texacort (hydroco | Suitability | 2025-04-09 | Granted | Epstein Becker Green |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$6.25
per ml
Lowest NADAC/Unit
$6.25
per ml
Brand NDCs
0
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00178045501TEXACORT 2.5% SOLUTION | $6.25 | ML | — | — | 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.