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Data / Drug companies / Schedule II

Companies that list Schedule II controlled substances: 196 companies and 2,232 products in the FDA NDC directory

The FDA National Drug Code Directory lists 2,232 products that are Schedule II controlled substances from 196 companies. The ten largest listers hold 31.3% of them, and the newest started marketing on October 1, 2026.

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Companies
196
Products
2,232
Drugs by generic name
59
Main marketing category
Generic drugs (ANDA)

Companies with the most Schedule II products

Ranked by number of products in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
SpecGx LLC140powder; tabletGeneric drugs (ANDA)August 28, 2025
Bryant Ranch Prepack89tablet; capsule, extended releaseGeneric drugs (ANDA)May 3, 2024
Bryant Ranch Prepack89tablet; capsule, extended releaseGeneric drugs (ANDA)February 11, 2021
Bryant Ranch Prepack73tablet; tablet, film coated, extended releaseGeneric drugs (ANDA)September 10, 2024
Camber Pharmaceuticals, Inc.69tablet; capsule, extended releaseGeneric drugs (ANDA)November 14, 2025
Rhodes Pharmaceuticals LLC54tablet; capsule, extended releaseGeneric drugs (ANDA)January 30, 2024
Lannett Company, Inc.52capsule, extended release; tabletGeneric drugs (ANDA)February 22, 2024
Granules Pharmaceuticals Inc.50capsule, extended release; tabletGeneric drugs (ANDA)January 29, 2025
Societal Cdmo Gainesville, LLC42capsule, extended releaseDrugs for further processingJune 1, 2025
Amneal Pharmaceuticals of New York LLC40capsule, extended release; tablet, film coated, extended releaseGeneric drugs (ANDA)October 5, 2018
Cambrex Charles City, Inc39powder; liquidBulk ingredientsJune 28, 2022
Hikma Pharmaceuticals USA Inc.39tablet; solutionGeneric drugs (ANDA)December 15, 2025
Aurolife Pharma, LLC37tablet; solutionGeneric drugs (ANDA)January 27, 2020
Alvogen Inc.36tablet; tablet, extended releaseGeneric drugs (ANDA)August 25, 2023
KVK-Tech, Inc.35tablet; solutionGeneric drugs (ANDA)December 5, 2019
Lupin Pharmaceuticals,Inc.35tablet; tablet, film coated, extended releaseGeneric drugs (ANDA)June 12, 2017
Sun Pharmaceutical Industries, Inc.33tablet; capsuleGeneric drugs (ANDA)December 20, 2024
XLCare Pharmaceuticals, Inc.32tablet; tablet, extended releaseGeneric drugs (ANDA)September 24, 2020
Elite Laboratories, Inc.30tablet; capsuleGeneric drugs (ANDA)November 15, 2024
Sandoz Inc29capsule, extended release; capsuleAuthorized generics (NDA)October 1, 2026
Epic Pharma, LLC28tablet; tablet, film coatedGeneric drugs (ANDA)December 31, 2021
Hikma Pharmaceuticals USA Inc.28injection; injection, solutionGeneric drugs (ANDA)August 29, 2025
Veranova, L.P.28powderBulk ingredientsJanuary 8, 2026
Asclemed USA, Inc.25tabletGeneric drugs (ANDA)September 10, 2024
American Health Packaging24tablet; solutionGeneric drugs (ANDA)September 9, 2026
Teva Pharmaceuticals, Inc.23capsule; tablet, orally disintegratingGeneric drugs (ANDA)December 8, 2025
Direct_Rx21tabletGeneric drugs (ANDA)November 25, 2025
Hospira, Inc.21injection, solutionNew drug applications (NDA)April 21, 2025
Chattem Chemicals, Inc.20powder; liquidBulk ingredientsJune 29, 2023
Mylan Pharmaceuticals Inc.19patch; capsuleGeneric drugs (ANDA)August 25, 2023
St. Mary's Medical Park Pharmacy19tabletGeneric drugs (ANDA)August 6, 2026
Cranbury Pharmaceuticals, LLC18tablet; solutionGeneric drugs (ANDA)August 20, 2022
Catalent Pharma Solutions, LLC16capsule; capsule, extended releaseDrugs for further processingApril 23, 2024
Fresenius Kabi USA, LLC16injection, solution; injection, powder, lyophilized, for solutionNew drug applications (NDA)January 15, 2021
Professional Compounding Centers of America DBA Pcca16powderBulk ingredients for compoundingDecember 1, 2025
Siegfried USA, LLC16powderBulk ingredientsNovember 22, 2023
Padagis US LLC15suppository; tablet, extended releaseOther unapproved drugsJune 5, 2023
Azurity Pharmaceuticals, Inc.14tablet; solutionGeneric drugs (ANDA)March 20, 2026
Eywa Pharma Inc14tablet; solutionGeneric drugs (ANDA)June 17, 2019
Redpharm Drug14tablet; solutionGeneric drugs (ANDA)September 10, 2024
Sandoz Inc14capsule, extended release; tabletNew drug applications (NDA)May 31, 2005
Amneal Pharmaceuticals LLC13tablet; capsuleGeneric drugs (ANDA)August 28, 2023
Collegium Pharmaceutical, Inc.13capsule, extended release; tablet, film coated, extended releaseNew drug applications (NDA)April 19, 2019
Knoa Pharma LLC13tablet, film coated, extended release; tablet, extended releaseNew drug applications (NDA)January 15, 2015
NuCare Pharmaceuticals,Inc.13tabletGeneric drugs (ANDA)July 13, 2018
Takeda Pharmaceuticals America, Inc.13capsule; tablet, chewableNew drug applications (NDA)January 28, 2017
Actavis Pharma, Inc.12capsule, extended releaseGeneric drugs (ANDA)February 4, 2014
Ascend Laboratories, LLC12tablet; solutionGeneric drugs (ANDA)July 1, 2025
Golden State Medical Supply, Inc.12tablet, extended release; capsule, extended releaseGeneric drugs (ANDA)November 26, 2021
Major Pharmaceuticals12tablet; tablet, film coated, extended releaseGeneric drugs (ANDA)January 3, 2024
NextWave Pharmaceuticals, Inc12suspension, extended release; tablet, extended releaseNew drug applications (NDA)November 4, 2021
NorthStar Rx LLC12tabletGeneric drugs (ANDA)March 20, 2019
Solco Healthcare US, LLC12capsule; tabletGeneric drugs (ANDA)August 26, 2023
Adare Pharmaceuticals Inc11capsule; tablet, orally disintegratingDrugs for further processingMay 16, 2019
Medisca Inc.11powderBulk ingredients for compoundingAugust 9, 2017
Patheon Manufacturing Services LLC11tablet; capsuleDrugs for further processingDecember 18, 2017
Proficient Rx LP11tabletGeneric drugs (ANDA)December 1, 2016
Trigen Laboratories, LLC11tablet, extended releaseGeneric drugs (ANDA)June 23, 2022
American Health Packaging10tablet; tablet, film coated, extended releaseGeneric drugs (ANDA)February 25, 2020
Amneal Pharmaceuticals LLC10tablet, film coated, extended release; capsule, extended releaseGeneric drugs (ANDA)January 2, 2013
Takeda Pharmaceuticals America, Inc.10capsule, extended releaseNew drug applications (NDA)June 20, 2017
Winder Laboratories LLC10tablet; solutionGeneric drugs (ANDA)December 6, 2021
Asclemed USA Inc.9tabletGeneric drugs (ANDA)June 1, 2019
Fresenius Kabi USA, LLC9injection, solutionNew drug applications (NDA)December 4, 2018
Neos Therapeutics Brands, LLC9tablet, orally disintegratingNew drug applications (NDA)June 20, 2017
Neos Therapeutics, LP9tablet, orally disintegratingAuthorized generics (NDA)July 1, 2026
Noramco, LLC9powderBulk ingredientsDecember 10, 2021
Novadoz Pharmaceuticals LLC9tablet, chewable; tablet, film coatedGeneric drugs (ANDA)September 3, 2026
Precision Dose, Inc.9solution; tabletNew drug applications (NDA)September 1, 2025
Spectrum Laboratory Products, Inc.9powder; crystalBulk ingredientsJanuary 1, 2002
Strides Pharma Science Limited9tabletGeneric drugs (ANDA)September 1, 2025
Sunrise Pharmaceutical, Inc.9tabletGeneric drugs (ANDA)July 4, 2018
Teva Pharmaceuticals USA, Inc.9tabletGeneric drugs (ANDA)March 19, 2003
Upsher-Smith Laboratories, LLC9capsule, extended release; tabletGeneric drugs (ANDA)July 22, 2019
Amneal Pharmaceuticals of New York LLC8tabletGeneric drugs (ANDA)February 18, 2010
Ascent Pharmaceuticals, Inc.8solution; tabletGeneric drugs (ANDA)January 29, 2021
Aveva Drug Delivery Systems Inc.8patch, extended releaseGeneric drugs (ANDA)February 11, 2025
Curia New York, Inc.8powderBulk ingredientsMay 2, 2018
Ingenus Pharmaceuticals, LLC8patch, extended releaseGeneric drugs (ANDA)February 11, 2025
Novartis Pharmaceuticals Corporation8capsule, extended releaseNew drug applications (NDA)May 31, 2005
Noven Therapeutics, LLC8patch, extended release; patchNew drug applications (NDA)May 15, 2023
Pai Holdings, LLC DBA Pai Pharma8solutionGeneric drugs (ANDA)September 15, 2025
Par Health USA, LLC8capsule, extended releaseGeneric drugs (ANDA)January 5, 2017
Pharma Source Direct, LLC.8powderBulk ingredientsJune 1, 2022
Teva Pharmaceuticals USA, Inc.8capsule, extended releaseGeneric drugs (ANDA)July 5, 2017
Actavis Pharma, Inc.7capsule, extended releaseGeneric drugs (ANDA)September 30, 2020
Apotex Corp.7capsuleGeneric drugs (ANDA)November 9, 2023
Genus Lifesciences7solution; tabletGeneric drugs (ANDA)May 15, 2026
Prasco Laboratories7capsule, extended release; solutionAuthorized generics (NDA)May 15, 2014
Teva Pharmaceuticals USA, Inc.7tabletGeneric drugs (ANDA)March 3, 2015
Vertical Pharmaceuticals, LLC7tablet, extended releaseNew drug applications (NDA)June 23, 2022
VistaPharm, LLC7tablet; concentrateGeneric drugs (ANDA)September 11, 2020
Wilshire Pharmaceuticals, Inc.7tabletGeneric drugs (ANDA)August 6, 2021
Ani Pharmaceuticals, Inc.6capsule, extended releaseGeneric drugs (ANDA)March 16, 2020
AvKARE6capsuleGeneric drugs (ANDA)June 4, 2025
AvPAK6tabletGeneric drugs (ANDA)July 9, 2018
Aytu BioPharma, Inc.6capsule, extended releaseNew drug applications (NDA)February 22, 2024
Burel Pharmaceuticals, LLC6capsule, extended releaseGeneric drugs (ANDA)December 16, 2019
Dr. Reddy's Laboratories Inc.6capsule, extended release; tabletGeneric drugs (ANDA)November 7, 2025
Letco Medical, LLC6powderBulk ingredients for compoundingMay 14, 2015

Drugs most often listed

DrugProducts hereCompanies listing it
Methylphenidate hydrochloride21139
Hydrocodone bitartrate and acetaminophen20237
Oxycodone hydrochloride13336
Oxycodone and acetaminophen11832
Morphine sulfate15031
Acetaminophen and codeine phosphate224
Methadone hydrochloride4921
Hydromorphone hydrochloride7420
Dexmethylphenidate hydrochloride11417
Dextroamphetamine sulfate5617
Lisdexamfetamine dimesylate14716
Amphetamine sulfate3012
Oxymorphone hydrochloride279
Levorphanol tartrate108
Dronabinol47
Tapentadol hydrochloride266
Oxycodone196
Oxycodone hydrochloride and acetaminophen146
Methylphenidate235
Fentanyl citrate175
Meperidine hydrochloride105
Hydrocodone bitartrate and homatropine methylbromide75
Fentanyl294
Amphetamine194
Remifentanil hydrochloride134
Lisdexamfetamine193
Dextroamphetamine63
Methamphetamine hydrochloride33
Hydrocodone bitartrate192
Codeine sulfate62
Hydrocodone bitartrate and ibuprofen52
Amphetamine sulfate tablets32
Atropa belladonna and opium32
Hydrocodone polistirex and chlorpheniramine polistirex32
Morphine22
Morphine tincture22
Oxycodone hydchloride22
Pentobarbital sodium22
Fentanyl transdermal71
Lisdexamfetamine dimesylate capsules71
Amphetamine extended-release61
Hydrocodone/apap51
Lisdexamfetamine dimesylate oral51
Oxycodone hcl51
Benzhydrocodone and acetaminophen31
Methylphenidate extended-release31
Serdexmethylphenidate and dexmethylphenidate31
Cocaine hydrochloride21
Cocaine hydrochloride nasal21
Methylphenidate hcl21
Methylphenidate hydrochloride extended release21
Oliceridine21
Oxycodone and acetaminophen tablets21
Oxycodone hydrochloride oral solution21
Oxycodone/apap21
Hydrocodone apap11
Methadone11
Oxycodone and aspirin11
Sufentanil citrate11

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.