Active ingredient
Baclofen
233 finished FDA listings contain Baclofen as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BACLOFEN
- Dosage forms
- Granule, Injection, Injection, Solution, Solution, Suspension, Tablet
- Routes
- Intrathecal, Oral
- Manufacturers / labelers
- 65
- Strengths listed
- .05 mg/ml · 10 mg/1 · 10 mg/5ml · 1000 ug/ml · 15 mg/1 · 20 mg/1 · 2000 ug/ml · 5 mg/1 · 5 mg/5ml · 5 mg/ml · 50 ug/ml · 500 ug/ml
- Brand names in FDA listings
- Baclofen (Intrathecal), Fleqsuvy, Gablofen, Lioresal (Baclofen), Lyvispah, Ozobax Ds
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1292
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 072234 | IVAX SUB TEVA PHARMS | 1988-07-21 | 5 |
| ANDA 072235 | IVAX SUB TEVA PHARMS | 1988-07-21 | 2 |
| NDA 020075 | AMNEAL | 1992-06-17 | 1 |
| ANDA 074584 | YILING | 1996-08-19 | 4 |
| ANDA 077068 | PH HEALTH | 2005-08-30 | 6 |
| ANDA 077241 | LANNETT CO INC | 2005-12-20 | 18 |
| ANDA 078504 | NORTHSTAR HLTHCARE | 2009-09-18 | 1 |
| ANDA 078401 | NORTHSTAR HLTHCARE | 2009-09-18 | 5 |
| NDA 022462 | PIRAMAL CRITICAL | 2010-11-19 | 4 |
| ANDA 209102 | RUBICON RESEARCH | 2017-11-28 | 35 |
| ANDA 211659 | ZYDUS LIFESCIENCES | 2018-11-23 | 20 |
| ANDA 211555 | ADAPTIS | 2019-02-01 | 5 |
| ANDA 210315 | MAIA PHARMS INC | 2019-07-30 | 2 |
| ANDA 210048 | MAIA PHARMS INC | 2019-09-11 | 4 |
| NDA 208193 | ROSEMOUNT | 2019-09-18 | 4 |
| ANDA 212067 | UNICHEM | 2020-07-09 | 15 |
| ANDA 212378 | ANDAS 5 HOLDING | 2020-10-09 | 30 |
| ANDA 214374 | RISING | 2021-03-05 | 13 |
| ANDA 214099 | AUROBINDO PHARMA LTD | 2021-07-13 | 16 |
| NDA 215422 | STRIDES PHARMA INTL | 2021-11-22 | 4 |
| ANDA 215885 | MANKIND PHARMA | 2022-01-25 | 13 |
| NDA 215602 | AZURITY | 2022-02-04 | 2 |
| ANDA 217324 | RUBICON RESEARCH | 2023-02-22 | 4 |
| ANDA 217252 | ANI PHARMS | 2023-06-08 | 2 |
| ANDA 214445 | RUBICON RESEARCH | 2024-12-06 | 3 |
Official labeling on DailyMed
- BACLOFEN SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 6 · 2026-09-10
- BACLOFEN TABLET [REMEDYREPACK INC.] · version 2 · 2026-09-10
- BACLOFEN TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- BACLOFEN TABLET [PAR HEALTH USA, LLC] · version 24 · 2026-09-07
- BACLOFEN TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-02
- BACLOFEN TABLET [BRYANT RANCH PREPACK] · version 4 · 2026-08-25
- BACLOFEN TABLET [REMEDYREPACK INC.] · version 9 · 2026-08-17
- BACLOFEN TABLET [REMEDYREPACK INC.] · version 8 · 2026-08-11
- BACLOFEN TABLET [REMEDYREPACK INC.] · version 7 · 2026-08-06
- BACLOFEN TABLET [CARDINAL HEALTH 107, LLC] · version 4 · 2026-08-03
- BACLOFEN TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-07-24
- BACLOFEN TABLET [EYWA PHARMA INC] · version 7 · 2026-07-16
Showing the 12 most recent of 169 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.