Data / Drug companies / Dexmethylphenidate hydrochloride
Dexmethylphenidate hydrochloride: 17 companies and 114 products in the FDA NDC directory
Dexmethylphenidate hydrochloride is listed in the FDA National Drug Code Directory by 17 companies, with 114 products in commercial distribution. 87 of the products (76.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule, extended release; tablet, and the newest product started marketing on October 1, 2026.
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- Companies listing it
- 17
- Products
- 114
- Generic (ANDA) products
- 87 (76.3%)
- Application numbers
- 17
- Controlled substance schedule
- Schedule II
- Routes
- Oral
- Brand names
- Focalin XR, Focalin
- openFDA record search
- api.fda.gov
Companies that list dexmethylphenidate hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 13 | capsule, extended release; tablet | Generic drugs (ANDA) | May 3, 2024 |
| Sandoz Inc | 11 | capsule, extended release; tablet | New drug applications (NDA) | May 31, 2005 |
| Bryant Ranch Prepack | 10 | capsule, extended release; tablet | Generic drugs (ANDA) | January 5, 2017 |
| Camber Pharmaceuticals, Inc. | 8 | capsule, extended release | Generic drugs (ANDA) | December 8, 2021 |
| Granules Pharmaceuticals Inc. | 8 | capsule, extended release | Generic drugs (ANDA) | December 1, 2020 |
| Lannett Company, Inc. | 8 | capsule, extended release | Generic drugs (ANDA) | October 9, 2018 |
| Novartis Pharmaceuticals Corporation | 8 | capsule, extended release | New drug applications (NDA) | May 31, 2005 |
| Par Health USA, LLC | 8 | capsule, extended release | Generic drugs (ANDA) | January 5, 2017 |
| Sandoz Inc | 8 | capsule, extended release | Authorized generics (NDA) | October 1, 2026 |
| Teva Pharmaceuticals USA, Inc. | 8 | capsule, extended release | Generic drugs (ANDA) | July 5, 2017 |
| Amneal Pharmaceuticals of New York LLC | 7 | capsule, extended release | Generic drugs (ANDA) | July 5, 2017 |
| Ascend Laboratories, LLC | 3 | tablet | Generic drugs (ANDA) | July 21, 2019 |
| Cranbury Pharmaceuticals, LLC | 3 | tablet | Generic drugs (ANDA) | November 30, 2001 |
| KVK-Tech, Inc. | 3 | tablet | Generic drugs (ANDA) | December 4, 2015 |
| Lupin Pharmaceuticals,Inc. | 3 | tablet | Generic drugs (ANDA) | December 4, 2015 |
| Sun Pharmaceutical Industries, Inc. | 3 | tablet | Generic drugs (ANDA) | September 26, 2013 |
| Nivagen Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | May 3, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule, extended release | 86 | 75.4% |
| Tablet | 28 | 24.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 87 | 76.3% |
| New drug applications (NDA) | 19 | 16.7% |
| Authorized generics (NDA) | 8 | 7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Central Nervous System Stimulant | 114 |
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.