Active ingredient
Methotrexate
77 finished FDA listings contain Methotrexate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METHOTREXATE, METHOTREXATE SODIUM
- Dosage forms
- Injection, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Solution, Tablet, Tablet, Film Coated
- Routes
- Intra-Arterial, Intramuscular, Intrathecal, Intravenous, Oral, Subcutaneous
- Manufacturers / labelers
- 33
- Strengths listed
- 1 g/1 · 10 mg/.2ml · 10 mg/.4ml · 10 mg/1 · 100 mg/4ml · 12.5 mg/.25ml · 12.5 mg/.4ml · 15 mg/.3ml · 15 mg/.4ml · 15 mg/1 · 17.5 mg/.35ml · 17.5 mg/.4ml · 2 mg/ml · 2.5 mg/1 · 2.5 mg/ml · 20 mg/.4ml · 200 mg/8ml · 22.5 mg/.45ml · 22.5 mg/.4ml · 25 mg/.4ml · 25 mg/.5ml · 25 mg/ml · 250 mg/10ml · 30 mg/.6ml · 5 mg/1 · 50 mg/2ml · 7.5 mg/.15ml · 7.5 mg/1
- Brand names in FDA listings
- Jylamvo, Methotrexate, Otrexup, Rasuvo, Trexall, Xatmep
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6851
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 011719 | HOSPIRA | 1959-08-10 | 6 |
| ANDA 089340 | HIKMA | 1986-09-16 | 1 |
| ANDA 089343 | HIKMA | 1986-09-16 | 1 |
| ANDA 089342 | HIKMA | 1986-09-16 | 1 |
| ANDA 089341 | HIKMA | 1986-09-16 | 1 |
| ANDA 081099 | BARR | 1990-10-15 | 4 |
| ANDA 081235 | MYLAN | 1992-05-15 | 5 |
| ANDA 040054 | HIKMA | 1994-08-01 | 1 |
| ANDA 040266 | FRESENIUS KABI USA | 1999-02-26 | 1 |
| ANDA 040263 | FRESENIUS KABI USA | 1999-02-26 | 1 |
| ANDA 040385 | BARR | 2001-03-21 | 4 |
| ANDA 040632 | HIKMA | 2005-08-12 | 2 |
| ANDA 040716 | ACCORD HLTHCARE | 2007-04-30 | 1 |
| ANDA 040843 | PHARMACHEMIE BV | 2010-01-08 | 3 |
| ANDA 201529 | EUGIA PHARMA SPECLTS | 2012-03-29 | 4 |
| NDA 204824 | COSETTE | 2013-10-11 | 7 |
| NDA 205776 | MEDEXUS | 2014-07-10 | 9 |
| ANDA 201749 | SUN PHARM | 2015-05-21 | 2 |
| ANDA 207812 | ZYDUS PHARMS | 2017-01-13 | 4 |
| NDA 208400 | AZURITY | 2017-04-25 | 1 |
| ANDA 213343 | ACCORD HLTHCARE | 2020-01-24 | 5 |
| ANDA 210454 | EUGIA PHARMA | 2020-01-30 | 4 |
| NDA 212479 | SHORLA | 2022-11-29 | 1 |
| ANDA 216453 | ELITE LABS INC | 2024-05-16 | 1 |
| ANDA 217552 | ALEMBIC | 2024-06-03 | 3 |
| ANDA 220225 | ALEMBIC | 2026-04-15 | 4 |
Official labeling on DailyMed
- METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.] · version 7 · 2026-09-07
- METHOTREXATE TABLET [A-S MEDICATION SOLUTIONS] · version 17 · 2026-08-28
- METHOTREXATE TABLET [AVKARE] · version 6 · 2026-07-27
- METHOTREXATE TABLET [ALEMBIC PHARMACEUTICALS INC.] · version 6 · 2026-06-30
- TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH LLC] · version 14 · 2026-06-29
- METHOTREXATE TABLET [TEVA PHARMACEUTICALS USA, INC.] · version 17 · 2026-06-17
- METHOTREXATE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-06-11
- JYLAMVO (METHOTREXATE) SOLUTION [SHORLA ONCOLOGY INC.] · version 13 · 2026-06-10
- METHOTREXATE TABLET [MAJOR PHARMACEUTICALS] · version 7 · 2026-06-10
- METHOTREXATE TABLET [BRYANT RANCH PREPACK] · version 6 · 2026-06-08
- METHOTREXATE (METHOTREXATE SODIUM) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 10 · 2026-06-04
- XATMEP (METHOTREXATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] · version 12 · 2026-05-29
Showing the 12 most recent of 47 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.