Active ingredient
Methocarbamol
211 finished FDA listings contain Methocarbamol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHOCARBAMOL
- Dosage forms
- Injection, Injection, Solution, Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Intramuscular, Intravenous, Oral
- Manufacturers / labelers
- 67
- Strengths listed
- 100 mg/ml · 1000 mg/1 · 1000 mg/10ml · 500 mg/1 · 750 mg/1 · 750 mg/5ml
- Brand names in FDA listings
- Atmeksi, Methocarbamol, Methocarbamol Tablets, Usp, 500 Mg, Methocarbamol Tablets, Usp, 750 Mg, Robaxin, Tanlor
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6845
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 011790 | HIKMA | 1959-06-10 | 2 |
| ANDA 086988 | PRINSTON INC | 1979-10-29 | 13 |
| ANDA 040489 | OXFORD PHARMS | 2003-01-29 | 54 |
| ANDA 090200 | HETERO LABS LTD III | 2009-11-06 | 31 |
| ANDA 200958 | BOSTAL | 2011-10-21 | 6 |
| ANDA 206128 | EUGIA PHARMA | 2016-05-27 | 2 |
| ANDA 208116 | HAINAN POLY | 2017-01-19 | 1 |
| ANDA 203550 | PHARMOBEDIENT | 2017-02-08 | 1 |
| ANDA 205404 | SAGENT PHARMS INC | 2017-07-18 | 1 |
| ANDA 208507 | REGCON HOLDINGS | 2017-07-21 | 17 |
| ANDA 207522 | SOMERSET THERAPS LLC | 2017-07-31 | 1 |
| ANDA 209331 | FRESENIUS KABI USA | 2018-04-17 | 1 |
| ANDA 209312 | GRANULES | 2018-05-07 | 40 |
| ANDA 211504 | GLAND | 2018-10-26 | 5 |
| ANDA 213967 | AUROBINDO PHARMA LTD | 2020-08-12 | 16 |
| ANDA 212623 | POINTVIEW HLDINGS | 2021-04-30 | 11 |
| ANDA 215065 | BAXTER HLTHCARE CORP | 2022-07-14 | 1 |
| ANDA 212707 | MIKART | 2023-06-12 | 2 |
| NDA 219843 | ROSEMONT PHARMS | 2025-07-30 | 1 |
Official labeling on DailyMed
- METHOCARBAMOL TABLET [CARDINAL HEALTH 107, LLC] · version 6 · 2026-09-07
- METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [COUPLER LLC] · version 1 · 2026-09-02
- METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [REMEDYREPACK INC.] · version 3 · 2026-08-11
- METHOCARBAMOL TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 2 · 2026-08-07
- METHOCARBAMOL TABLET [COUPLER LLC] · version 1 · 2026-08-05
- METHOCARBAMOL (METHOCARBAMOL) TABLET, FILM COATED [MEDCORE LLC] · version 1 · 2026-08-03
- METHOCARBAMOL TABLET [AMERICAN HEALTH PACKAGING] · version 6 · 2026-08-03
- METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.] · version 8 · 2026-07-31
- METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.] · version 8 · 2026-07-31
- METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.] · version 9 · 2026-07-31
- METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.] · version 9 · 2026-07-23
- METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [REMEDYREPACK INC.] · version 21 · 2026-07-13
Showing the 12 most recent of 173 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.