Active ingredient
Armodafinil
37 finished FDA listings contain Armodafinil as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ARMODAFINIL
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 14
- Strengths listed
- 150 mg/1 · 200 mg/1 · 250 mg/1 · 50 mg/1
- Brand names in FDA listings
- Nuvigil
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 641465
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021875 | NUVO PHARMS | 2007-06-15 | 19 |
| ANDA 200043 | MYLAN PHARMS INC | 2012-06-01 | 4 |
| ANDA 202768 | NATCO PHARMA LTD | 2016-11-28 | 4 |
| ANDA 206069 | AUROBINDO PHARMA LTD | 2018-03-06 | 10 |
Official labeling on DailyMed
- ARMODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-03-09
- ARMODAFINIL TABLET [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-03-09
- ARMODAFINIL TABLET [BRYANT RANCH PREPACK] · version 1 · 2026-02-06
- ARMODAFINIL TABLET [SANDOZ INC] · version 16 · 2025-11-20
- NUVIGIL (ARMODAFINIL) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2025-09-05
- NUVIGIL (ARMODAFINIL) TABLET [CEPHALON, LLC] · version 32 · 2025-05-07
- ARMODAFINIL TABLET [TEVA PHARMACEUTICALS USA, INC.] · version 16 · 2025-02-03
- ARMODAFINIL TABLET [DIRECT_RX] · version 2 · 2025-01-23
- ARMODAFINIL TABLET [DIRECTRX] · version 3 · 2025-01-23
- ARMODAFINIL TABLET [DIRECT RX] · version 4 · 2025-01-21
- ARMODAFINIL TABLET [QUALITY CARE PRODUCTS LLC] · version 8 · 2025-01-01
- ARMODAFINIL TABLET [MYLAN PHARMACEUTICALS INC.] · version 5 · 2024-07-12
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.