Data / Drug companies / Methotrexate
Methotrexate: 31 companies and 72 products in the FDA NDC directory
Methotrexate is listed in the FDA National Drug Code Directory by 31 companies, with 72 products in commercial distribution. 48 of the products (66.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; tablet; solution, and the newest product started marketing on October 29, 2026.
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- Companies listing it
- 31
- Products
- 72
- Generic (ANDA) products
- 48 (66.7%)
- Application numbers
- 21
- Routes
- Oral, Subcutaneous, Intramuscular, Intravenous, Intrathecal
- Brand names
- Rasuvo, Otrexup, Trexall, Xatmep, Jylamvo
- openFDA record search
- api.fda.gov
Companies that list methotrexate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Medexus Pharma, Inc. | 9 | injection, solution | New drug applications (NDA) | July 10, 2014 |
| Antares Pharma, Inc. | 7 | injection, solution | New drug applications (NDA) | October 11, 2013 |
| Hikma Pharmaceuticals USA Inc. | 6 | solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 5, 2018 |
| Hospira, Inc. | 6 | injection, solution | New drug applications (NDA) | November 4, 2024 |
| Bryant Ranch Prepack | 4 | tablet | Generic drugs (ANDA) | August 24, 2020 |
| Eugia US LLC | 4 | injection, solution | Generic drugs (ANDA) | September 11, 2024 |
| Teva Women's Health LLC | 4 | tablet, film coated | Generic drugs (ANDA) | May 3, 2001 |
| Alembic Pharmaceuticals Inc. | 3 | injection, solution; tablet | Generic drugs (ANDA) | April 15, 2026 |
| Alembic Pharmaceuticals Limited | 3 | injection, solution; tablet | Generic drugs (ANDA) | April 15, 2026 |
| Teva Parenteral Medicines, Inc. | 3 | injection, solution | Generic drugs (ANDA) | August 1, 2012 |
| Accord Healthcare Inc. | 2 | injection; tablet | Generic drugs (ANDA) | August 24, 2020 |
| NuCare Pharmaceuticals,Inc. | 2 | tablet | Generic drugs (ANDA) | August 24, 2020 |
| A-S Medication Solutions | 1 | tablet | Generic drugs (ANDA) | November 1, 1990 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | October 29, 2026 |
| Aurobindo Pharma Limited | 1 | tablet | Generic drugs (ANDA) | January 30, 2020 |
| AvKARE | 1 | tablet | Generic drugs (ANDA) | November 20, 2014 |
| AvPAK | 1 | tablet | Generic drugs (ANDA) | January 29, 2026 |
| Azurity Pharmaceuticals, Inc. | 1 | solution | New drug applications (NDA) | May 1, 2017 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | June 4, 2024 |
| Chartwell RX, LLC | 1 | tablet | Generic drugs (ANDA) | January 30, 2020 |
| Coupler LLC | 1 | tablet | Generic drugs (ANDA) | February 27, 2025 |
| Golden State Medical Supply, Inc. | 1 | tablet | Generic drugs (ANDA) | May 15, 1992 |
| Major Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | February 9, 2017 |
| Mylan Institutional Inc. | 1 | tablet | Generic drugs (ANDA) | July 13, 1995 |
| Mylan Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | May 18, 1992 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | August 24, 2020 |
| Safecor Health, LLC | 1 | tablet | Generic drugs (ANDA) | January 19, 2026 |
| Shorla Oncology Inc. | 1 | solution | New drug applications (NDA) | December 15, 2023 |
| Teva Pharmaceuticals USA, Inc. | 1 | tablet | Generic drugs (ANDA) | November 1, 1990 |
| Zydus Lifesciences Limited | 1 | tablet | Generic drugs (ANDA) | February 9, 2017 |
| Zydus Pharmaceuticals USA Inc. | 1 | tablet | Generic drugs (ANDA) | February 9, 2017 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 33 | 45.8% |
| Tablet | 26 | 36.1% |
| Solution | 6 | 8.3% |
| Tablet, film coated | 4 | 5.6% |
| Injection, powder, lyophilized, for solution | 2 | 2.8% |
| Injection | 1 | 1.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 48 | 66.7% |
| New drug applications (NDA) | 24 | 33.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Folate Analog Metabolic Inhibitor | 72 |
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.