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Data / Drug companies / Methylphenidate hydrochloride

Methylphenidate hydrochloride: 39 companies and 211 products in the FDA NDC directory

Methylphenidate hydrochloride is listed in the FDA National Drug Code Directory by 39 companies, with 211 products in commercial distribution. 156 of the products (73.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, extended release; capsule, extended release; tablet, and the newest product started marketing on February 1, 2025.

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Companies listing it
39
Products
211
Generic (ANDA) products
156 (73.9%)
Application numbers
46
Controlled substance schedule
Schedule II
Routes
Oral
Brand names
Metadate CD, Relexxii, Jornay PM Extended-Release, Quillivant XR, Concerta, QuilliChew Er, Ritalin, Methylphenidate
openFDA record search
api.fda.gov

Companies that list methylphenidate hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Lannett Company, Inc.16capsule, extended release; tablet, extended releaseNew drug applications (NDA)February 22, 2024
Bryant Ranch Prepack14tablet; solutionGeneric drugs (ANDA)April 16, 2024
SpecGx LLC14capsule, extended release; tablet, extended releaseGeneric drugs (ANDA)September 29, 2015
Camber Pharmaceuticals, Inc.10tablet, extended release; tablet, chewableGeneric drugs (ANDA)September 3, 2019
XLCare Pharmaceuticals, Inc.10tablet, extended release; tablet, chewableGeneric drugs (ANDA)February 26, 2020
Amneal Pharmaceuticals of New York LLC9capsule, extended release; tabletGeneric drugs (ANDA)September 20, 2016
Lupin Pharmaceuticals,Inc.8tablet, chewable; tabletGeneric drugs (ANDA)January 20, 2016
Actavis Pharma, Inc.7capsule, extended releaseGeneric drugs (ANDA)September 30, 2020
Granules Pharmaceuticals Inc.7capsule, extended release; tablet, extended releaseGeneric drugs (ANDA)September 10, 2019
NextWave Pharmaceuticals, Inc7suspension, extended release; tablet, chewable, extended releaseNew drug applications (NDA)April 18, 2016
Rhodes Pharmaceuticals LLC7capsule, extended releaseAuthorized generics (NDA)April 1, 2020
Trigen Laboratories, LLC7tablet, extended releaseGeneric drugs (ANDA)June 23, 2022
Vertical Pharmaceuticals, LLC7tablet, extended releaseNew drug applications (NDA)June 23, 2022
Aytu BioPharma, Inc.6capsule, extended releaseNew drug applications (NDA)February 22, 2024
Golden State Medical Supply, Inc.6tablet, extended releaseGeneric drugs (ANDA)November 21, 2018
Ascend Laboratories, LLC5tablet; solutionGeneric drugs (ANDA)April 1, 2020
Dr. Reddy's Laboratories Inc.5capsule, extended releaseGeneric drugs (ANDA)December 20, 2024
Ironshore Pharmaceuticals Inc.5capsuleNew drug applications (NDA)June 1, 2019
KVK-Tech, Inc.5tablet; solutionGeneric drugs (ANDA)May 11, 2017
Actavis Pharma, Inc.4tablet, film coated, extended releaseGeneric drugs (ANDA)March 4, 2019
American Health Packaging4tablet, extended releaseGeneric drugs (ANDA)June 25, 2020
Janssen Pharmaceuticals, Inc.4tablet, extended releaseNew drug applications (NDA)August 1, 2000
Lannett Company, Inc.4tablet, extended releaseGeneric drugs (ANDA)September 23, 2013
Sun Pharmaceutical Industries, Inc.4tablet; tablet, extended releaseGeneric drugs (ANDA)December 20, 2024
Accord Healthcare Inc.3tabletGeneric drugs (ANDA)December 23, 2020
Aurolife Pharma, LLC3tabletGeneric drugs (ANDA)April 11, 2017
Bryant Ranch Prepack3solution; tabletGeneric drugs (ANDA)March 29, 2019
Nivagen Pharmaceuticals, Inc.3tabletGeneric drugs (ANDA)April 16, 2024
Rising Pharma Holdings, Inc.3tablet, chewableGeneric drugs (ANDA)December 18, 2018
Sandoz Inc3tabletNew drug applications (NDA)December 31, 1955
Solco Healthcare US, LLC3tabletGeneric drugs (ANDA)July 1, 2020
American Health Packaging2tabletGeneric drugs (ANDA)September 30, 2014
Ascent Pharmaceuticals, Inc.2solutionGeneric drugs (ANDA)January 29, 2021
Bryant Ranch Prepack2tabletGeneric drugs (ANDA)April 16, 2024
Cranbury Pharmaceuticals, LLC2solutionGeneric drugs (ANDA)March 4, 2015
Eywa Pharma Inc2solutionGeneric drugs (ANDA)March 29, 2019
Quagen Pharmaceuticals LLC2solutionGeneric drugs (ANDA)June 4, 2020
Shionogi Inc.2solutionNew drug applications (NDA)December 19, 2002
NorthStar RxLLC1tablet, extended releaseGeneric drugs (ANDA)February 1, 2025

Dosage forms

Dosage formProductsShare
Tablet, extended release5526.1%
Capsule, extended release5425.6%
Tablet5124.2%
Solution2210.4%
Tablet, chewable136.2%
Capsule52.4%
Suspension, extended release41.9%
Tablet, film coated, extended release41.9%
Tablet, chewable, extended release31.4%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)15673.9%
New drug applications (NDA)4019%
Authorized generics (NDA)157.1%

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.