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Data / Drug companies / Schedule III

Companies that list Schedule III controlled substances: 226 companies and 969 products in the FDA NDC directory

The FDA National Drug Code Directory lists 969 products that are Schedule III controlled substances from 226 companies. The ten largest listers hold 19.7% of them, and the newest started marketing on October 20, 2026.

SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.

Companies
226
Products
969
Drugs by generic name
40
Main marketing category
Generic drugs (ANDA)

Companies with the most Schedule III products

Ranked by number of products in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack38tablet; injection, solutionGeneric drugs (ANDA)May 20, 2024
Bryant Ranch Prepack23tablet; capsuleGeneric drugs (ANDA)June 15, 2024
Bryant Ranch Prepack21tablet; capsuleGeneric drugs (ANDA)December 15, 2020
Professional Compounding Centers of America DBA Pcca18powderBulk ingredients for compoundingMarch 17, 2025
A-S Medication Solutions16tablet; injection, solutionGeneric drugs (ANDA)November 1, 2024
Asclemed USA, Inc.16injection, solution; powderGeneric drugs (ANDA)November 2, 2022
Remedyrepack Inc.16tablet; injectionGeneric drugs (ANDA)April 16, 2026
NuCare Pharmaceuticals,Inc.15tablet; injection, solutionGeneric drugs (ANDA)May 20, 2024
Deseret Biologicals, Inc.14liquid; tabletUnapproved homeopathic productsJune 15, 2026
Letco Medical, LLC14powderBulk ingredients for compoundingJanuary 29, 2026
Clinical Solutions Wholesale, LLC13tabletGeneric drugs (ANDA)September 1, 2020
Camber Pharmaceuticals, Inc.12film, soluble; tabletGeneric drugs (ANDA)May 1, 2026
Redpharm Drug12tablet; filmGeneric drugs (ANDA)August 29, 2023
SCH Global Services Private Limited12powderBulk ingredients for compoundingOctober 20, 2026
SpecGx LLC12tablet; powderGeneric drugs (ANDA)January 19, 2026
Pharma Source Direct, LLC.11powderBulk ingredientsSeptember 1, 2026
Pharmacia & Upjohn Company LLC11powder; injection, solutionBulk ingredientsMay 24, 2016
Sun Pharmaceutical Industries, Inc.11tablet; powderGeneric drugs (ANDA)May 12, 2020
Alvogen Inc.10film; patch, extended releaseGeneric drugs (ANDA)November 2, 2022
Medisca Inc.10powderBulk ingredientsAugust 6, 2026
Actavis Pharma, Inc.9gel; capsuleGeneric drugs (ANDA)February 12, 2021
Aveva Drug Delivery Systems Inc.9patch, extended release; filmGeneric drugs (ANDA)March 7, 2025
Brichem Sciences Private Limited9powderBulk ingredients for compoundingOctober 20, 2026
Ingenus Pharmaceuticals, LLC9patch, extended release; filmGeneric drugs (ANDA)November 1, 2023
Rhodes Pharmaceuticals LLC9patch; tabletAuthorized generics (NDA)April 13, 2020
Advanced Rx of Tennessee, LLC8tablet; capsuleGeneric drugs (ANDA)January 8, 2026
Eugia US LLC8injection; injection, solutionGeneric drugs (ANDA)February 28, 2024
Method Pharmaceuticals, LLC8tabletOther unapproved drugsMarch 10, 2025
Preferred Pharmaceuticals Inc.8tabletGeneric drugs (ANDA)June 9, 2026
Sun Pharmaceutical Industries, Inc.8tablet, film coated; suspensionGeneric drugs (ANDA)June 16, 2026
Symbiotec Pharmalab Limited8powderBulk ingredientsJune 22, 2018
Amneal Pharmaceuticals NY LLC7patch, extended release; gel, meteredGeneric drugs (ANDA)April 20, 2020
Asg Biochem Pvt. LTD7powderBulk ingredientsFebruary 1, 2026
Aspen Oss B.V.7powderBulk ingredientsNovember 18, 1999
BioDelivery Sciences International Inc7film, solubleNew drug applications (NDA)October 1, 2017
Braeburn Inc.7injectionNew drug applications (NDA)June 6, 2023
Catalent Pharma Solutions, LLC7for suspension, extended release; capsuleDrugs for further processingJanuary 1, 2026
Catalyst Pharmaceuticals, Inc.7tablet; suspensionNew drug applications (NDA)January 2, 2024
Eisai Inc.7tablet; suspensionNew drug applications (NDA)April 30, 2016
Hikma Pharmaceuticals USA Inc.7injection; injection, solutionGeneric drugs (ANDA)November 22, 2021
Hikma Pharmaceuticals USA Inc.7tablet; capsuleGeneric drugs (ANDA)January 3, 2023
Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.7powderBulk ingredientsJanuary 2, 2014
Major Pharmaceuticals7tablet; capsuleGeneric drugs (ANDA)March 3, 2021
Novadoz Pharmaceuticals LLC7tablet, film coated; suspensionGeneric drugs (ANDA)November 25, 2025
Proficient Rx LP7tablet; injectionGeneric drugs (ANDA)January 5, 2017
Apex Energetics Inc.6solution/ dropsUnapproved homeopathic productsMarch 22, 2022
Aurobindo Pharma Limited6tablet, film coatedGeneric drugs (ANDA)October 2, 2026
BioActive Nutritional, Inc.6liquid; sprayUnapproved homeopathic productsJanuary 3, 2025
Direct_Rx6tabletGeneric drugs (ANDA)January 2, 2025
Edenbridge Pharmaceuticals LLC.6tablet, orally disintegratingNew drug applications (NDA)June 12, 2026
Eisai Co., Ltd.6tabletDrugs for further processingOctober 22, 2012
Eisai Manufacturing Ltd6tabletDrugs for further processingSeptember 27, 2012
Indivior Inc.6film, soluble; solutionNew drug applications (NDA)February 26, 2018
Nuray Chemicals Private Limited6powderBulk ingredientsApril 20, 2026
Orexo US, Inc.6tablet, orally disintegratingNew drug applications (NDA)December 11, 2014
Shakti Lifescience Private Limited6powderBulk ingredientsFebruary 14, 2025
Steroid S.p.A.6powder; injection, solutionBulk ingredientsJanuary 9, 2025
Teva Pharmaceuticals, Inc.6tablet, film coatedGeneric drugs (ANDA)May 29, 2025
Unit Dose Solutions, Inc.6tabletGeneric drugs (ANDA)June 30, 2026
Alkermes, Inc.5for suspension, extended release; kitNew drug applications (NDA)October 7, 2024
Arevipharma GmbH5powderBulk ingredientsJanuary 13, 2022
Ascend Laboratories, LLC5capsule; tabletAuthorized generics (NDA)July 3, 2026
AvPAK5tabletGeneric drugs (ANDA)March 19, 2024
Chattem Chemicals, Inc.5powderBulk ingredientsFebruary 26, 2021
Cu Chemie Uetikon GmbH5powderBulk ingredientsSeptember 30, 2011
Dr. Reddy's Laboratories Inc.5film, soluble; gel, meteredGeneric drugs (ANDA)April 12, 2019
F.i.s. Fabbrica Italiana Sintetici S.p.a.5powderBulk ingredientsNovember 19, 2018
Hospira, Inc.5injection, solution; injection, solution, concentrateGeneric drugs (ANDA)August 1, 2016
KVK-Tech, Inc.5tabletGeneric drugs (ANDA)September 26, 2018
Knoa Pharma LLC5patch, extended releaseNew drug applications (NDA)February 14, 2011
Prasco Laboratories5gelAuthorized generics (NDA)May 19, 2025
Quagen Pharmaceuticals LLC5tablet; capsuleGeneric drugs (ANDA)May 1, 2024
Siegfried USA, LLC5powderBulk ingredientsFebruary 27, 2015
Teva Pharmaceuticals USA, Inc.5patch, extended releaseGeneric drugs (ANDA)December 27, 2021
Actavis Pharma, Inc.4tabletGeneric drugs (ANDA)February 19, 2015
Advagen Pharma Ltd4tabletGeneric drugs (ANDA)February 1, 2026
American Health Packaging4tabletGeneric drugs (ANDA)March 14, 2022
Amici Pharma, Inc.4tablet; capsuleGeneric drugs (ANDA)April 10, 2026
Amneal Pharmaceuticals LLC4tablet; solutionGeneric drugs (ANDA)September 12, 2025
Aurolife Pharma, LLC4tablet; capsuleGeneric drugs (ANDA)April 26, 2017
Cipla USA Inc.4injection; solutionGeneric drugs (ANDA)September 15, 2023
Fresenius Kabi USA, LLC4injectionGeneric drugs (ANDA)July 10, 2023
Gland Pharma Limited4injection, solution; injectionGeneric drugs (ANDA)October 15, 2026
LGM Pharma Solutions, LLC4capsule; tabletGeneric drugs (ANDA)October 18, 2021
Meribel Pharma Pessac4for suspension, extended releaseDrugs for further processingMay 1, 2023
Mylan Pharmaceuticals Inc.4filmGeneric drugs (ANDA)April 17, 2020
Padagis Israel Pharmaceuticals Ltd4gel; solutionGeneric drugs (ANDA)June 27, 2019
Pai Holdings, LLC DBA Pai Pharma4tabletGeneric drugs (ANDA)October 12, 2023
Par Health USA, LLC4injectionNew drug applications (NDA)July 30, 2015
Strides Pharma Science Limited4gel; tabletGeneric drugs (ANDA)May 20, 2024
Xiromed, LLC4injection, solution; gel, meteredGeneric drugs (ANDA)April 28, 2023
Antares Pharma, Inc.3injectionNew drug applications (NDA)November 15, 2018
Ax Pharmaceutical Corp3powderBulk ingredients for compoundingSeptember 3, 2026
Bayer de Mexico, S.A. de C.V.3powderBulk ingredientsAugust 6, 2018
Curia Spain S.a.u.3powderBulk ingredients for compoundingFebruary 19, 2016
Elite Laboratories, Inc.3tabletGeneric drugs (ANDA)September 10, 2019
Encube Ethicals, Inc.3gel; solutionGeneric drugs (ANDA)June 19, 2026
Eywa Pharma Inc3tabletGeneric drugs (ANDA)August 2, 2019
Golden State Medical Supply, Inc.3tabletGeneric drugs (ANDA)June 27, 2014
Granules Pharmaceuticals Inc.3tablet; capsuleGeneric drugs (ANDA)June 29, 2022

Drugs most often listed

DrugProducts hereCompanies listing it
Buprenorphine7324
Acetaminophen and codeine phosphate6324
Testosterone cypionate6124
Butalbital, acetaminophen and caffeine3523
Buprenorphine and naloxone6522
Testosterone4722
Butalbital, acetaminophen, and caffeine2322
Phendimetrazine tartrate2013
Ketamine hydrochloride2811
Buprenorphine hydrochloride2110
Butalbital and acetaminophen139
Esterified estrogens and methyltestosterone147
Dronabinol117
Perampanel406
Buprenorphine hcl106
Sodium oxybate106
Acetaminophen and codeine76
Benzphetamine hydrochloride66
Butalbital, aspirin, and caffeine55
Esterified estrogens, methyltestosterone114
Testosterone undecanoate84
Butalbital, acetaminophen, caffeine and codeine phosphate54
Buprenorphine hydrochloride and naloxone hydrochloride143
Testosterone enanthate53
Butalbital, aspirin, caffeine and codeine phosphate33
Butalbital, acetaminophen, caffeine, and codeine phosphate32
Methyltestosterone32
Testosterone gel, 1%22
Buprenorphine hydrochloride, naloxone hydrochloride41
Buprenorphine sublingual c-iii21
Acetaminophen, caffeine, dihydrocodeine bitartrate11
Buprenorphine sublingual11
Butal/apap/caff11
Butal/apap/caffeine11
Butalbital and acetaminophen tablets11
Butalbital, aspirin, cafeine, and codeine phosphate11
Butalbital/acetaminophen/caffeine11
Calcium, magnesium, potassium, and sodium oxybates11
Codeine phosphate and chlorpheniramine maleate11
Esketamine hydrochloride11

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.