ZALEPLON | A077237 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a | Other | 2015-12-16 | Open | Daniel F. Kripke, MD (The Weston Firm) |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0289 Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Zaleplon Capsules, 7.5 mg, suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, with the reference listed drug | Other | 2008-05-16 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1558
per ea
Lowest NADAC/Unit
$0.1491
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054008425ZALEPLON 5 MG CAPSULE | $0.1558 | EA | Generic | — | 2026-10-21 |
| 00054008525ZALEPLON 10 MG CAPSULE | $0.1491 | 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.