Drug
Who makes dexmethylphenidate hydrochloride?
15 companies list dexmethylphenidate hydrochloride as a human prescription drug, including under the names Focalin, Focalin XR. Forms: capsule, extended release; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing dexmethylphenidate hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | capsule, extended release; tablet | ANDAANDA078992, ANDA202842, ANDA207901 | 23 | 1 |
| Sandoz Industrial Products S.AAustria | capsule, extended release; tablet | NDANDA021278, NDA021802 | 11 | 5 |
| Novartis Pharmaceuticals CorporationSwitzerland | capsule, extended release | NDANDA021802 | 8 | 20 |
| Granules Pharmaceuticals Inc.India | capsule, extended release | ANDAANDA213813 | 8 | 8 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, extended release | ANDAANDA078908, ANDA202731 | 8 | 6 |
| Par Health USA, LLCIndia | capsule, extended release | ANDAANDA078992, ANDA202842 | 8 | 5 |
| Camber Pharmaceuticals, Inc.United States | capsule, extended release | ANDAANDA215523 | 8 | 1 |
| Lannett Company, LLCUnited States | capsule, extended release | ANDAANDA210279 | 8 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule, extended release | ANDAANDA079108, ANDA203614 | 7 | 14 |
| Lupin LimitedIndia | tablet | ANDAANDA204534 | 3 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA201231 | 3 | 13 |
| KVK-TECH, INC.United States | tablet | ANDAANDA206931 | 3 | 2 |
| Cranbury Pharmaceuticals IncUnited States | tablet | ANDAANDA207901 | 3 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA212631 | 3 | 0 |
| Nivagen Pharmaceuticals LLCUnited States | tablet | ANDAANDA209211 | 2 | 2 |
Bulk ingredient listings
- Curia Missouri, Inc.United States · 1 NDC
- Curia New York, Inc. · 1 NDC
- Purisys LLCUnited States · 1 NDC
- S&B Pharma LLC dba Norac PharmaUnited States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- SpecGx LLCUnited States · 1 NDC
Enquiry
Common questions
- Who makes dexmethylphenidate hydrochloride?
- 15 companies list dexmethylphenidate hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Sandoz Industrial Products S.A, Novartis Pharmaceuticals Corporation, Granules Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Focalin?
- 13 companies list dexmethylphenidate hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dexmethylphenidate hydrochloride active ingredient?
- 6 companies list dexmethylphenidate hydrochloride as a bulk ingredient, including Curia Missouri, Inc., Curia New York, Inc., Purisys LLC, S&B Pharma LLC dba Norac Pharma.