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Data / Drug companies / Baclofen

Baclofen: 65 companies and 234 products in the FDA NDC directory

Baclofen is listed in the FDA National Drug Code Directory by 65 companies, with 234 products in commercial distribution. 217 of the products (92.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection; solution, and the newest product started marketing on October 26, 2026.

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Companies listing it
65
Products
234
Generic (ANDA) products
217 (92.7%)
Application numbers
27
Routes
Oral, Intrathecal
Brand names
Lyvispah, Ozobax DS, Fleqsuvy
openFDA record search
api.fda.gov

Companies that list baclofen

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack21tabletGeneric drugs (ANDA)June 15, 2024
Advanced Rx of Tennessee, LLC13tabletGeneric drugs (ANDA)December 10, 2025
Bryant Ranch Prepack12tabletGeneric drugs (ANDA)October 14, 2020
Remedyrepack Inc.11tabletGeneric drugs (ANDA)May 12, 2026
Advagen Pharma Ltd9tablet; injectionGeneric drugs (ANDA)June 3, 2025
Bryant Ranch Prepack9tabletGeneric drugs (ANDA)June 15, 2024
A-S Medication Solutions8tabletGeneric drugs (ANDA)December 6, 2018
Preferred Pharmaceuticals Inc.7tabletGeneric drugs (ANDA)July 22, 2026
Amneal Pharmaceuticals LLC6kit; injectionNew drug applications (NDA)June 12, 2022
Aphena Pharma Solutions - Tennessee, LLC6tabletGeneric drugs (ANDA)January 25, 2022
Asclemed USA, Inc.6tabletGeneric drugs (ANDA)February 5, 2024
Method Pharmaceuticals, LLC6tabletGeneric drugs (ANDA)June 1, 2025
Major Pharmaceuticals5tabletGeneric drugs (ANDA)November 1, 2025
PD-Rx Pharmaceuticals, Inc.5tabletGeneric drugs (ANDA)April 1, 2018
TruPharma, LLC5tablet; solutionGeneric drugs (ANDA)February 5, 2024
Cardinal Health 107, LLC4tabletGeneric drugs (ANDA)March 23, 2026
Maia Pharmaceuticals, Inc.4injectionGeneric drugs (ANDA)April 2, 2021
NuCare Pharmaceuticals,Inc.4tabletGeneric drugs (ANDA)March 1, 2024
Proficient Rx LP4tabletGeneric drugs (ANDA)December 1, 2005
Sagent Pharmaceuticals4injection, solutionGeneric drugs (ANDA)July 15, 2021
Zydus Lifesciences Limited4tabletGeneric drugs (ANDA)June 20, 2024
Zydus Pharmaceuticals USA Inc.4tabletGeneric drugs (ANDA)June 20, 2024
American Health Packaging3tabletGeneric drugs (ANDA)May 26, 2024
Amneal Pharmaceuticals LLC3granuleNew drug applications (NDA)June 1, 2023
AvPAK3tabletGeneric drugs (ANDA)May 11, 2021
Chartwell RX, LLC3tabletGeneric drugs (ANDA)September 22, 2021
Eywa Pharma Inc3tabletGeneric drugs (ANDA)May 27, 2021
Golden State Medical Supply, Inc.3tabletGeneric drugs (ANDA)January 25, 2022
Lannett Company, Inc.3tabletGeneric drugs (ANDA)September 22, 2021
Lifestar Pharma LLC3tabletGeneric drugs (ANDA)January 26, 2022
NCS HealthCare of Ky, LLC DBA Vangard Labs3tabletGeneric drugs (ANDA)January 26, 2022
Rising Pharma Holdings, Inc.3tabletGeneric drugs (ANDA)March 1, 2024
Unichem Pharmaceuticals (USA), Inc.3tabletGeneric drugs (ANDA)June 15, 2023
XLCare Pharmaceuticals, Inc.3tabletGeneric drugs (ANDA)February 5, 2025
Aurobindo Pharma Limited2tabletGeneric drugs (ANDA)July 13, 2021
Direct_Rx2tabletGeneric drugs (ANDA)June 28, 2024
Marlex Pharmaceuticals, Inc.2tabletGeneric drugs (ANDA)May 1, 2020
Medcore LLC2tabletGeneric drugs (ANDA)March 27, 2026
NorthStar Rx LLC2tabletGeneric drugs (ANDA)January 1, 2011
PD-Rx Pharmaceuticals, Inc.2tabletGeneric drugs (ANDA)July 1, 2007
Par Health USA, LLC2tabletGeneric drugs (ANDA)August 30, 2005
Proficient Rx LP2tabletGeneric drugs (ANDA)April 1, 2018
Redpharm Drug2tabletGeneric drugs (ANDA)July 9, 2020
Teva Pharmaceuticals USA, Inc.2tabletGeneric drugs (ANDA)July 21, 1988
Acella Pharmaceuticals, LLC1solutionNew drug applications (NDA)October 26, 2026
Ani Pharmaceuticals, Inc.1suspensionGeneric drugs (ANDA)March 18, 2024
Anvi Pharmaceuticals Inc1granuleNew drug applications (NDA)September 1, 2026
Aphena Pharma Solutions - Tennessee, LLC1tabletGeneric drugs (ANDA)August 30, 2005
Atlantic Biologicals Corp.1solutionAuthorized generics (NDA)October 12, 2023
Aurobindo Pharma Limited1tabletGeneric drugs (ANDA)November 21, 2025
Azurity Pharmaceuticals, Inc.1suspensionNew drug applications (NDA)February 7, 2022
Coupler LLC1tabletGeneric drugs (ANDA)April 23, 2026
Hawaii Repack, Inc.1tabletGeneric drugs (ANDA)July 13, 2021
Nexus Pharmaceuticals LLC1injectionGeneric drugs (ANDA)February 22, 2023
Northwind Health Company, LLC1tabletGeneric drugs (ANDA)September 27, 2023
PD-Rx Pharmaceuticals, Inc.1tabletGeneric drugs (ANDA)July 21, 1988
Palmetto Pharmaceuticals Inc.1solutionAuthorized generics (NDA)September 25, 2024
Phoenix RX LLC1tabletGeneric drugs (ANDA)July 9, 2020
Proficient Rx LP1tabletGeneric drugs (ANDA)January 1, 2011
Quality Care Products, LLC1tabletGeneric drugs (ANDA)May 21, 2024
Rosemont Pharmaceuticals LLC1solutionNew drug applications (NDA)October 12, 2023
Slayback Pharma LLC1suspensionGeneric drugs (ANDA)June 19, 2023
Sola Pharmaceuticals, LLC1tabletGeneric drugs (ANDA)March 21, 2025
Trifluent Pharma, LLC1solutionGeneric drugs (ANDA)June 5, 2025
Wilshire Pharmaceuticals, Inc.1suspensionAuthorized generics (NDA)April 1, 2023

Dosage forms

Dosage formProductsShare
Tablet20085.5%
Injection93.8%
Solution83.4%
Kit52.1%
Injection, solution41.7%
Suspension41.7%
Granule41.7%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)21792.7%
New drug applications (NDA)135.6%
Authorized generics (NDA)41.7%

Pharmacologic classes

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.