MODAFINIL | N020717 | NUVO PHARMACEUTICALS (IRELAND) DAC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma LLC FDA-2026-P-6706 · 6 docket documents Appco Pharma LLC filed a citizen petition requesting that the FDA determine the suitability of a drug substance or manufacturing process under FDA regulatory authority. The petition seeks FDA guidance on whether the proposed formulation or manufacturing approach meets regulatory requirements for pha | Suitability | 2026-06-11 | Open | Appco Pharma LLC |
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$80.25
per ea
Lowest NADAC/Unit
$0.2539
per ea
Brand NDCs
4
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63459020130PROVIGIL 200 MG TABLET | $80.25 | EA | Brand | $0.3526 | 2026-10-21 |
| 60505485203PROVIGIL 200 MG TABLET | $80.25 | EA | Brand | $0.3526 | 2026-10-21 |
| 63459010130PROVIGIL 100 MG TABLET | $53.18 | EA | Brand | $0.2539 | 2026-10-21 |
| 60505485103PROVIGIL 100 MG TABLET | $53.18 | EA | Brand | $0.2539 | 2026-10-21 |
| 55253080290MODAFINIL 200 MG TABLET | $0.3526 | EA | Generic | — | 2026-10-21 |
| 55253080130MODAFINIL 100 MG TABLET | $0.2539 | 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.