Drug
Who makes methotrexate?
28 companies list methotrexate as a human prescription drug, including under the names JYLAMVO, Otrexup, Rasuvo, Xatmep, Trexall. Forms: injection; injection, powder, lyophilized, for solution; injection, solution; solution; tablet; tablet, film coated. Routes: intra-arterial, intramuscular, intrathecal, intravenous, oral, subcutaneous.
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 methotrexate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Medexus Pharma, Inc. | injection, solution | NDANDA205776 | 9 | 0 |
| Antares Pharma, IncUnited States | injection, solution | NDANDA204824 | 7 | 1 |
| Alembic Pharmaceuticals LimitedIndia | injection, solution; tablet | ANDAANDA217552, ANDA220225 | 6 | 7 |
| Hikma Pharmaceuticals USA Inc.United States | injection, powder, lyophilized, for solution; solution | ANDAANDA040632, ANDA089340, ANDA089341 | 6 | 4 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA081099, ANDA081235, ANDA210454 | 5 | 1 |
| Hospira, Inc.United States | injection, solution | NDANDA011719 | 4 | 7 |
| Teva Women's Health LLCUnited States | tablet, film coated | ANDAANDA040385 | 4 | 1 |
| Eugia US LLC | injection, solution | ANDAANDA201529 | 4 | 0 |
| Teva Parenteral Medicines, Inc. | injection, solution | ANDAANDA040843 | 3 | 0 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection; tablet | ANDAANDA040716, ANDA213343 | 2 | 2 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA210454, ANDA213343 | 2 | 1 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA207812 | 1 | 12 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA210454 | 1 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA081099 | 1 | 6 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA081099 | 1 | 3 |
| Safecor Health, LLCUnited States | tablet | ANDAANDA081235 | 1 | 3 |
| Coupler LLCUnited States | tablet | ANDAANDA213343 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA081235 | 1 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA213343 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA207812 | 1 | 1 |
| AvKARE | tablet | ANDAANDA081099 | 1 | 0 |
| AvPAK | tablet | ANDAANDA207812 | 1 | 0 |
| Azurity Pharmaceuticals, Inc. | solution | NDANDA208400 | 1 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA210454 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA207812 | 1 | 0 |
| Mylan Institutional Inc. | tablet | ANDAANDA081235 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet | ANDAANDA081235 | 1 | 0 |
| Shorla Oncology Inc., | solution | NDANDA212479 | 1 | 0 |
Bulk ingredient listings
- Excella GmbH & Co. KGGermany · 3 NDC
- Fermion OyFinland · 1 NDC
- Huzhou Zhanwang Pharmaceutical Co., Ltd.China · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Zhejiang Hisun Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
15 unexpired patents list methotrexate as the active ingredient, expiring between Oct 2026 and Oct 2035. Application holders: COSETTE PHARMACEUTICALS INC, MEDEXUS PHARMA INC, SHORLA PHARMA LTD.
Enquiry
Common questions
- Who makes methotrexate?
- 28 companies list methotrexate as a human prescription drug in the openFDA NDC Directory, led by Medexus Pharma, Inc., Antares Pharma, Inc, Alembic Pharmaceuticals Limited, Hikma Pharmaceuticals USA Inc., Bryant Ranch Prepack. 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 JYLAMVO?
- 23 companies list methotrexate under an abbreviated new drug application (ANDA), the application type used for generics, and 5 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies methotrexate active ingredient?
- 7 companies list methotrexate as a bulk ingredient, including Excella GmbH & Co. KG, Fermion Oy, Huzhou Zhanwang Pharmaceutical Co., Ltd., MSN Laboratories Private Limited,.