Data / Drug companies / Methylphenidate
Methylphenidate: 5 companies and 23 products in the FDA NDC directory
Methylphenidate is listed in the FDA National Drug Code Directory by 5 companies, with 23 products in commercial distribution. 4 of the products (17.4%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are patch; capsule, extended release; tablet, orally disintegrating, and the newest product started marketing on June 5, 2023.
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- Companies listing it
- 5
- Products
- 23
- Generic (ANDA) products
- 4 (17.4%)
- Application numbers
- 4
- Controlled substance schedule
- Schedule II
- Routes
- Transdermal, Oral
- Brand names
- Daytrana, Cotempla Xr-Odt
- openFDA record search
- api.fda.gov
Companies that list methylphenidate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Sandoz Inc | 8 | capsule, extended release | Authorized generics (NDA) | November 24, 2015 |
| Mylan Pharmaceuticals Inc. | 4 | patch | Generic drugs (ANDA) | June 27, 2022 |
| Noven Therapeutics, LLC | 4 | patch | New drug applications (NDA) | April 6, 2006 |
| Padagis US LLC | 4 | patch | Authorized generics (NDA) | June 5, 2023 |
| Neos Therapeutics Brands, LLC | 3 | tablet, orally disintegrating | New drug applications (NDA) | June 20, 2017 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Patch | 12 | 52.2% |
| Capsule, extended release | 8 | 34.8% |
| Tablet, orally disintegrating | 3 | 13% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Authorized generics (NDA) | 12 | 52.2% |
| New drug applications (NDA) | 7 | 30.4% |
| Generic drugs (ANDA) | 4 | 17.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Central Nervous System Stimulant | 23 |
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.