Drug
Who makes methotrexate sodium?
5 companies list methotrexate sodium as a human prescription drug. Forms: injection, powder, lyophilized, for solution; injection, solution; tablet. Routes: intra-arterial, intramuscular, intrathecal, intravenous, 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 methotrexate sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution; injection, solution | ANDAANDA040263, ANDA040266 | 2 | 6 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA201749 | 1 | 13 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA040054 | 1 | 4 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA201749 | 1 | 1 |
| Elite Laboratories, Inc.United States | tablet | ANDAANDA216453 | 1 | 1 |
Bulk ingredient listings
- Alembic Pharmaceuticals LimitedIndia · 1 NDC
- Fermion OyFinland · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
Orange Book patents
7 unexpired patents list methotrexate sodium as the active ingredient, expiring between Jan 2033 and Jan 2033. Application holder: AZURITY PHARMACEUTICALS INC.
Enquiry
Common questions
- Who makes methotrexate sodium?
- 5 companies list methotrexate sodium as a human prescription drug in the openFDA NDC Directory, led by Fresenius Kabi USA, LLC, Sun Pharmaceutical Industries Limited, Hikma Pharmaceuticals USA Inc., Bryant Ranch Prepack, Elite Laboratories, 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 methotrexate sodium?
- 5 companies list methotrexate sodium under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies methotrexate sodium active ingredient?
- 3 companies list methotrexate sodium as a bulk ingredient, including Alembic Pharmaceuticals Limited, Fermion Oy, MSN Laboratories Private Limited,.