ARMODAFINIL | A200043 | MYLAN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen’s Health Research Group FDA-2025-P-1449 · 20 docket documents Public Citizen's Health Research Group filed this petition under the Federal Food, Drug, and Cosmetic Act sections 352 and 505(o)(4) requesting that the FDA contraindicate modafinil (PROVIGIL and generics) and armodafinil (NUVIGIL and generics) during pregnancy and in females of reproductive potenti | Other | 2025-05-29 | Open | Public Citizen’s Health Research Group |
Actavis, Inc. - Citizen Petition FDA-2010-P-0579 · 7 docket documents Actavis, Inc. filed this citizen petition on November 9, 2010, requesting that the FDA determine that Nuvigil (armodafinil) Tablets in 100 mg and 200 mg strengths, approved under NDA 21-875 and discontinued in February 2010, were not voluntarily withdrawn for safety or efficacy reasons, as required | 505(q) | 2010-11-22 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.9472
per ea
Lowest NADAC/Unit
$0.2871
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00378343393ARMODAFINIL 250 MG TABLET | $0.9472 | EA | Generic | — | 2026-06-17 |
| 00378343293ARMODAFINIL 150 MG TABLET | $0.8003 | EA | Generic | — | 2026-06-17 |
| 00378343193ARMODAFINIL 50 MG TABLET | $0.2871 | 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.