Drug
Who makes methylphenidate?
5 companies list methylphenidate as a human prescription drug, including under the names Cotempla XR-ODT, Daytrana. Forms: capsule, extended release; patch; tablet, orally disintegrating. Routes: oral, transdermal.
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 methylphenidate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sandoz Industrial Products S.AAustria | capsule, extended release | NDA AUTHORIZED GENERICNDA021284 | 8 | 5 |
| Padagis Israel Pharmaceuticals LtdUnited States | patch | NDA AUTHORIZED GENERICNDA021514 | 4 | 2 |
| Noven Pharmaceuticals, Inc.United States | patch | NDANDA021514 | 4 | 1 |
| Mylan Pharmaceuticals, Inc. | patch | ANDAANDA206497 | 4 | 0 |
| Neos Therapeutics Brands, LLC | tablet, orally disintegrating | NDANDA205489 | 3 | 0 |
Bulk ingredient listings
- Professional Compounding Center of America · 1 NDC
- SpecGx LLCUnited States · 1 NDC
Orange Book patents
3 unexpired patents list methylphenidate as the active ingredient, expiring between Jun 2032 and Jan 2038. Application holder: NEOS THERAPEUTICS INC.
Enquiry
Common questions
- Who makes methylphenidate?
- 5 companies list methylphenidate as a human prescription drug in the openFDA NDC Directory, led by Sandoz Industrial Products S.A, Padagis Israel Pharmaceuticals Ltd, Noven Pharmaceuticals, Inc., Mylan Pharmaceuticals, Inc., Neos Therapeutics Brands, LLC. 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 Cotempla XR-ODT?
- 1 company lists methylphenidate 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 methylphenidate active ingredient?
- 2 companies list methylphenidate as a bulk ingredient, including Professional Compounding Center of America, SpecGx LLC.