Active ingredient
Metaxalone
61 finished FDA listings contain Metaxalone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METAXALONE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 34
- Strengths listed
- 400 mg/1 · 640 mg/1 · 800 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 59078
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 |
|---|---|---|---|
| ANDA 203399 | AMNEAL PHARMS | 2013-06-21 | 7 |
| ANDA 040486 | MOUNTAIN | 2015-02-27 | 1 |
| NDA 022503 | PRIMUS PHARMS | 2015-06-01 | 1 |
| ANDA 204770 | LANNETT CO INC | 2016-11-22 | 22 |
| ANDA 203695 | ACTAVIS LABS FL INC | 2017-06-15 | 11 |
| ANDA 207466 | SCIEGEN PHARMS | 2017-08-31 | 19 |
Official labeling on DailyMed
- METAXALONE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 3 · 2026-09-03
- METAXALONE TABLET [REMEDYREPACK INC.] · version 2 · 2026-08-28
- METAXALONE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-07-27
- METAXALONE TABLET [REMEDYREPACK INC.] · version 18 · 2026-07-01
- METAXALONE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-06-19
- METAXALONE TABLET [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-06-19
- METAXALONE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] · version 12 · 2026-06-11
- METAXALONE TABLET [DIRECT_RX] · version 2 · 2026-05-13
- METAXALONE TABLET [DIRECT RX] · version 3 · 2026-05-13
- METAXALONE TABLET [DIRECT_RX] · version 2 · 2026-05-13
- METAXALONE TABLET [ ST. MARY'S MEDICAL PARK PHARMACY] · version 5 · 2026-05-07
- METAXALONE TABLET [HIGHMARK PHARMA LLC] · version 1 · 2026-04-30
Showing the 12 most recent of 58 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.