Drug
Who makes baclofen?
59 companies list baclofen as a human prescription drug, including under the names FLEQSUVY, LYVISPAH, OZOBAX DS. Forms: granule; injection; injection, solution; kit; solution; suspension; tablet. Routes: intrathecal, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing baclofen
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA077068, ANDA077156, ANDA077241 | 42 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA209102, ANDA212067, ANDA212378 | 11 | 1 |
| Amneal Ireland LimitedIreland | granule; injection; kit | NDANDA020075, NDA215422 | 9 | 1 |
| Advagen Pharma Limited | injection; solution; tablet | ANDAANDA209102, ANDA214445, ANDA217324 | 9 | 0 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA074584, ANDA078401, ANDA209102 | 8 | 3 |
| PD-Rx Pharmaceuticals Inc.United States | tablet | ANDAANDA072234, ANDA077241, ANDA078220 | 8 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA078220, ANDA212067, ANDA214099 | 7 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA072234, ANDA072235, ANDA077241 | 7 | 1 |
| Advanced Rx of Tennessee, LLC | tablet | ANDAANDA072234, ANDA078401, ANDA209102 | 7 | 0 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet | ANDAANDA077156, ANDA077241, ANDA078220 | 7 | 0 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet | ANDAANDA077241, ANDA209102, ANDA212067 | 6 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet | ANDAANDA209102, ANDA214099 | 6 | 1 |
| Method Pharmaceuticals, LLC. | tablet | ANDAANDA212378 | 6 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA077241, ANDA078220, ANDA209102 | 5 | 0 |
| TruPharma LLC. | solution; tablet | ANDA, NDA AUTHORIZED GENERICANDA209102, NDA208193 | 5 | 0 |
| Cardinal Health 418, Inc.United States | tablet | ANDAANDA077241, ANDA078220, ANDA211659 | 4 | 34 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA211659 | 4 | 12 |
| SINTETICA S.A.Switzerland | injection | DRUG FOR FURTHER PROCESSING | 4 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA211659 | 4 | 1 |
| Sagent Pharmaceuticals | injection, solution | ANDAANDA210048, ANDA210315, ANDA210777 | 4 | 0 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA214099 | 3 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA211659 | 3 | 5 |
| Unichem Laboratories Limited, IndiaIndia | tablet | ANDAANDA212067 | 3 | 5 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA215885 | 3 | 1 |
| Lannett Company, LLCUnited States | tablet | ANDAANDA077241, ANDA078220 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA209102, ANDA215885 | 3 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA211555, ANDA214099, ANDA214374 | 3 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA214374 | 3 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet | ANDAANDA212378 | 3 | 1 |
| AvPAK | tablet | ANDAANDA211659 | 3 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA077241 | 3 | 0 |
| Eywa Pharma Inc | tablet | ANDAANDA211555 | 3 | 0 |
| Lifestar Pharma LLC. | tablet | ANDAANDA215885 | 3 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA072234, ANDA072235 | 2 | 6 |
| Par Health USA, LLCIndia | tablet | ANDAANDA077068 | 2 | 5 |
| Direct RxUnited States | tablet | ANDAANDA209102, ANDA214374 | 2 | 1 |
| Marlex Pharmaceuticals, IncUnited States | tablet | ANDAANDA077241 | 2 | 1 |
| Medcore llcUnited States | tablet | ANDAANDA214099 | 2 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA209102, ANDA212067 | 2 | 1 |
| MAIA Pharmaceuticals, Inc. | injection | ANDAANDA210048 | 2 | 0 |
| MAlA Pharmaceuticals, Inc. | injection | ANDAANDA210315, ANDA210777 | 2 | 0 |
| NorthStar RxLLC | tablet | ANDAANDA078401 | 2 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet | ANDAANDA074584 | 2 | 0 |
| ANI Pharmaceuticals, Inc.United States | suspension | ANDAANDA217252 | 1 | 1 |
| Coupler LLCUnited States | tablet | ANDAANDA211659 | 1 | 1 |
| HAWAII REPACK INCUnited States | tablet | ANDAANDA214099 | 1 | 1 |
| Nexus Pharmaceuticals, LLCUnited States | injection | ANDAANDA217324 | 1 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA072234 | 1 | 1 |
| PHOENIX RX LLCUnited States | tablet | ANDAANDA212067 | 1 | 1 |
| Rosemont Pharmaceuticals LimitedUnited Kingdom | solution | NDANDA208193 | 1 | 1 |
| South Atlantic Corporation LLCUnited States | solution | NDA AUTHORIZED GENERICNDA208193 | 1 | 1 |
| Trifluent Pharma LLCUnited States | solution | ANDAANDA214445 | 1 | 1 |
| Anvi Pharmaceuticals Inc | granule | NDANDA215422 | 1 | 0 |
| Azurity Pharmaceuticals, Inc. | suspension | NDANDA215602 | 1 | 0 |
| Palmetto Pharmaceuticals Inc. | solution | NDA AUTHORIZED GENERICNDA208193 | 1 | 0 |
| Quality Care Products, LLC | tablet | ANDAANDA214099 | 1 | 0 |
| SOLA Pharmaceuticals, LLC | tablet | ANDAANDA209102 | 1 | 0 |
| Slayback Pharma LLC | suspension | ANDAANDA217252 | 1 | 0 |
| Wilshire Pharmaceuticals, Inc. | suspension | NDA AUTHORIZED GENERICNDA215602 | 1 | 0 |
Bulk ingredient listings
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 3 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 3 NDC
- Excella GmbH & Co. KGGermany · 2 NDC
- MEDISCA Inc.United States · 2 NDC
- Mankind Pharma LimitedIndia · 2 NDC
- Medilux Laboratories PVT LtdIndia · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- Fine Chemicals Corporation (PTY) Ltd.South Africa · 1 NDC
- Galenova IncCanada · 1 NDC
- Kalchem International Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- PCAS Finland OyFinland · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Unichem Laboratories Limited, IndiaIndia · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
- Viyash Scientific LimitedIndia · 1 NDC
- XENEX LABORATORIES INCCanada · 1 NDC
Orange Book patents
8 unexpired patents list baclofen as the active ingredient, expiring between Sept 2037 and Sept 2041. Application holders: AZURITY PHARMACEUTICALS INC, ROSEMOUNT PHARMACEUTICALS LLC, STRIDES PHARMA INTERNATIONAL AG.
Enquiry
Common questions
- Who makes baclofen?
- 59 companies list baclofen as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, RemedyRepack, Inc, Amneal Ireland Limited, Advagen Pharma Limited, International Medication Systems, Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic FLEQSUVY?
- 51 companies list baclofen under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies baclofen active ingredient?
- 20 companies list baclofen as a bulk ingredient, including ASCLEMED USA INC. DBA ENOVACHEM, Professional Compounding Centers of America dba PCCA, Excella GmbH & Co. KG, MEDISCA Inc..