Data / Drug companies / Methotrexate sodium
Methotrexate sodium: 5 companies and 6 products in the FDA NDC directory
Methotrexate sodium is listed in the FDA National Drug Code Directory by 5 companies, with 6 products in commercial distribution. 6 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; injection, solution; injection, powder, lyophilized, for solution, and the newest product started marketing on May 16, 2024.
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- Companies listing it
- 5
- Products
- 6
- Generic (ANDA) products
- 6 (100.0%)
- Application numbers
- 5
- Routes
- Oral, Intra-arterial, Intramuscular, Intravenous, Intrathecal
- Brand names
- Methotrexate
- openFDA record search
- api.fda.gov
Companies that list methotrexate sodium
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 2 | injection, solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | September 10, 2001 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | November 10, 2017 |
| Elite Laboratories, Inc. | 1 | tablet | Generic drugs (ANDA) | May 16, 2024 |
| Hikma Pharmaceuticals USA Inc. | 1 | tablet | Generic drugs (ANDA) | August 1, 1994 |
| Sun Pharmaceutical Industries, Inc. | 1 | tablet | Generic drugs (ANDA) | November 10, 2017 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 4 | 66.7% |
| Injection, solution | 1 | 16.7% |
| Injection, powder, lyophilized, for solution | 1 | 16.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 6 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Folate Analog Metabolic Inhibitor | 6 |
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.