Drug
Who makes methylphenidate hydrochloride?
38 companies list methylphenidate hydrochloride as a human prescription drug, including under the names CONCERTA, JORNAY PM Extended-Release, METADATE CD, Methylin, QuilliChew ER, Quillivant XR, RELEXXII, Ritalin. Forms: capsule; capsule, extended release; solution; suspension, extended release; tablet; tablet, chewable; tablet, chewable, extended release; tablet, extended release; tablet, film coated, extended release. 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 methylphenidate hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Lannett Company, LLCUnited States | capsule, extended release; tablet, extended release | ANDA, NDA, NDA AUTHORIZED GENERICANDA091695, ANDA211918, NDA021259 | 20 | 1 |
| Bryant Ranch PrepackUnited States | solution; tablet; tablet, chewable; tablet, extended release | ANDAANDA090710, ANDA091159, ANDA091601 | 19 | 1 |
| SpecGx LLCUnited States | capsule, extended release; tablet; tablet, extended release | ANDAANDA040300, ANDA075629, ANDA202608 | 14 | 5 |
| Actavis LLCUnited States | capsule, extended release; tablet, film coated, extended release | ANDAANDA076655, ANDA076772, ANDA208861 | 11 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet; tablet, chewable; tablet, extended release | ANDAANDA207416, ANDA210354, ANDA211009 | 10 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet; tablet, chewable; tablet, extended release | ANDAANDA207416, ANDA210354, ANDA211009 | 10 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | capsule, extended release; tablet | ANDAANDA091159, ANDA205105 | 9 | 14 |
| Lupin LimitedIndia | solution; tablet; tablet, chewable | ANDAANDA204115, ANDA204602, ANDA207884 | 8 | 14 |
| Granules Pharmaceuticals Inc.India | capsule, extended release; tablet, extended release | ANDAANDA210992, ANDA211796 | 7 | 8 |
| NextWave Pharmaceuticals, Inc | suspension, extended release; tablet, chewable, extended release | NDANDA202100, NDA207960 | 7 | 0 |
| Rhodes Pharmaceuticals LLC | capsule, extended release | NDA AUTHORIZED GENERICNDA205831 | 7 | 0 |
| Trigen Laboratories, LLC | tablet, extended release | ANDA, NDA AUTHORIZED GENERICANDA205327, NDA216117 | 7 | 0 |
| Vertical Pharmaceuticals, LLC | tablet, extended release | NDANDA216117 | 7 | 0 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet; tablet, extended release | ANDAANDA040300, ANDA211009 | 6 | 5 |
| Golden State Medical Supply Inc.United States | tablet, extended release | ANDAANDA205327, ANDA210992 | 6 | 1 |
| Aytu Therapeutics, LLC | capsule, extended release | NDANDA021259 | 6 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | capsule, extended release | ANDAANDA078458, ANDA200886 | 5 | 15 |
| KVK-TECH, INC.United States | solution; tablet | ANDAANDA206932, ANDA207485 | 5 | 2 |
| ASCEND Therapeutics US, LLC | solution; tablet | ANDAANDA211647, ANDA211779 | 5 | 0 |
| Ironshore Pharmaceuticals Inc. | capsule | NDANDA209311 | 5 | 0 |
| Novartis Pharmaceuticals CorporationSwitzerland | capsule, extended release | NDANDA021284 | 4 | 20 |
| Sun Pharmaceutical Industries LimitedIndia | tablet; tablet, extended release | ANDAANDA090710, ANDA217229 | 4 | 13 |
| Janssen Pharmaceuticals, Inc. | tablet, extended release | NDANDA021121 | 4 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | capsule, extended release | ANDAANDA079031 | 3 | 6 |
| Sandoz Industrial Products S.AAustria | tablet | NDANDA010187 | 3 | 5 |
| Aurolife Pharma LLCUnited States | tablet | ANDAANDA209276 | 3 | 3 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet | ANDAANDA213936 | 3 | 2 |
| Nivagen Pharmaceuticals LLCUnited States | tablet | ANDAANDA208737 | 3 | 2 |
| Rising Pharma Holdings, Inc.United States | tablet, chewable | ANDAANDA205756 | 3 | 1 |
| Solco healthcare U.S., LLC | tablet | ANDAANDA212697 | 3 | 0 |
| Shionogi Pharma Co., Ltd.Japan | solution | NDANDA021419 | 2 | 4 |
| QUAGEN PHARMACEUTICALS LLCUnited States | solution | ANDAANDA213567 | 2 | 2 |
| Ascent Pharmaceuticals IncUnited States | solution | ANDAANDA207417 | 2 | 1 |
| Cranbury Pharmaceuticals IncUnited States | solution | ANDAANDA091601 | 2 | 1 |
| Mayne Pharma International Pty Ltd.Australia | capsule, extended release | ANDAANDA078458 | 2 | 1 |
| Eywa Pharma Inc | solution | ANDAANDA210139 | 2 | 0 |
| Dr. Reddys Laboratories Limited | tablet, extended release | ANDAANDA213473 | 1 | 0 |
| Northstar Rx, LLC, | tablet, extended release | ANDAANDA217229 | 1 | 0 |
Bulk ingredient listings
- Cambrex Charles City, Inc. · 7 NDC
- Janssen Pharmaceuticals Sciences Unlimited Company · 2 NDC
- S&B Pharma LLC dba Norac PharmaUnited States · 2 NDC
- SpecGx LLCUnited States · 2 NDC
- Chattem Chemicals, Inc.United States · 1 NDC
- Curia Missouri, Inc.United States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
49 unexpired patents list methylphenidate hydrochloride as the active ingredient, expiring between Mar 2027 and Nov 2038. Application holders: IRONSHORE PHARMACEUTICALS INC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC, KNOA PHARMA LLC, NEXTWAVE PHARMACEUTICALS INC, NEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA INC, OSMOTICA PHARMACEUTICAL US LLC.
Enquiry
Common questions
- Who makes methylphenidate hydrochloride?
- 38 companies list methylphenidate hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Lannett Company, LLC, Bryant Ranch Prepack, SpecGx LLC, Actavis LLC, Camber Pharmaceuticals, Inc.. 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 CONCERTA?
- 29 companies list methylphenidate hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 9 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies methylphenidate hydrochloride active ingredient?
- 11 companies list methylphenidate hydrochloride as a bulk ingredient, including Cambrex Charles City, Inc., Janssen Pharmaceuticals Sciences Unlimited Company, S&B Pharma LLC dba Norac Pharma, SpecGx LLC.