Quick answers
- What is Methotrexate used for?
- The FDA-approved label (Rasuvo, Medexus Pharma Inc., December 15, 2025) says: “Rasuvo is a folate analog metabolic inhibitor indicated for the: Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy Limitation of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methotrexate have a boxed warning?
- Yes. The FDA label for Rasuvo has a boxed warning (“WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Methotrexate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 29, 2026). Ask your pharmacist about alternatives.
- Has Methotrexate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started September 22, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Methotrexate?
- 33 companies list prescription products of Methotrexate in the FDA NDC Directory, including Medexus Pharma Inc., Hikma Pharmaceuticals USA Inc. and Antares Pharma, Inc..
What Methotrexate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Rasuvo is a folate analog metabolic inhibitor indicated for the: Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy Limitation of Use …
— FDA label: Rasuvo, Medexus Pharma Inc., effective December 15, 2025. Read the full label on DailyMed →
The FDA has 45 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH
. Read it on the full label →
44 of 45 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Tablet · Solution · Tablet, film coated · Injection, powder, lyophilized, for solution · Injection |
|---|---|
| Route | Oral · Subcutaneous · Intramuscular · Intravenous · Intrathecal · Intra-arterial |
| Prescription products | 76 in the FDA NDC Directory |
| Brand names | Rasuvo, Otrexup, Trexall, Jylamvo, Xatmep |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| methotrexate 2.5 mg tablet | Generic | $0.1632 per tablet |
| methotrexate 2.5 mg/mL solution | Brand: Xatmep | $21.76 per mL |
| methotrexate 25 mg/mL injection | Generic | $0.7020–$1.75 per mL 2 packages, lowest to highest |
| methotrexate 25 mg/mL solution | Generic | $1.26 per mL |
| methotrexate sodium 10 mg tablet, film coated | Brand: Trexall | $48.15 per tablet |
| methotrexate sodium 10 mg/0.2 mL injection, solution | Brand: Rasuvo | $721.81 per mL |
| methotrexate sodium 12.5 mg/0.25 mL injection, solution | Brand: Rasuvo | $574.87 per mL |
| methotrexate sodium 15 mg/0.3 mL injection, solution | Brand: Rasuvo | $480.36 per mL |
| methotrexate sodium 17.5 mg/0.35 mL injection, solution | Brand: Rasuvo | $409.93 per mL |
| methotrexate sodium 2.5 mg tablet | Generic | $0.1632 per tablet |
| methotrexate sodium 20 mg/0.4 mL injection, solution | Brand: Rasuvo | $361.99 per mL |
| methotrexate sodium 25 mg/0.5 mL injection, solution | Brand: Rasuvo | $289.09 per mL |
| methotrexate sodium 25 mg/mL injection, solution | Generic | $0.7020–$3.12 per mL 6 packages, lowest to highest |
| methotrexate sodium 5 mg tablet, film coated | Brand: Trexall | $24.09 per tablet |
| methotrexate sodium 7.5 mg tablet, film coated | Brand: Trexall | $36.21 per tablet |
| methotrexate sodium 7.5 mg/0.15 mL injection, solution | Brand: Rasuvo | $960.29 per mL |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Medexus Pharma Inc.9 products
- Hikma Pharmaceuticals USA Inc.7 products
- Antares Pharma, Inc.7 products
- Hospira, Inc.6 products
- Bryant Ranch Prepack6 products
- Eugia US LLC4 products
- Teva Women's Health LLC4 products
- Alembic Pharmaceuticals Limited3 products
- Alembic Pharmaceuticals Inc.3 products
- Teva Parenteral Medicines, Inc.3 products
- NuCare Pharmaceuticals, Inc.2 products
- Accord Healthcare Inc.2 products
- Fresenius Kabi USA, LLC2 products
- Teva Pharmaceuticals USA, Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Aurobindo Pharma Limited1 product
- Proficient Rx LP1 product
- Safecor Health LLC1 product
- Chartwell RX, LLC1 product
- Mylan Pharmaceuticals Inc.1 product
- Mylan Institutional Inc.1 product
- AvKARE1 product
- Sun Pharmaceutical Industries, Inc.1 product
- A-S Medication Solutions1 product
- Elite Laboratories, Inc.1 product
- Coupler LLC1 product
- Shorla Oncology Inc.1 product
- Major Pharmaceuticals1 product
- Azurity Pharmaceuticals, Inc.1 product
- AvPAK1 product
- American Health Packaging1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Zydus Lifesciences Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA011719 METHOTREXATE LPF, METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM, METHOTREXATE SODIUM PRESERVATIVE FREE | Hospira | August 10, 1959 | 73, latest October 15, 2026 2026: Labeling · 2025: Labeling · 2023: Manufacturing (CMC) |
| NDA204824 OTREXUP, OTREXUP PFS | Cosette | October 11, 2013 | 9, latest December 26, 2019 2019: Labeling · 2019: Labeling · 2018: Labeling |
| NDA205776 RASUVO | Medexus | July 10, 2014 | 3, latest March 11, 2020 2020: Labeling · 2018: Labeling · 2015: Labeling |
| NDA208400 XATMEP | Azurity | April 25, 2017 | 2, latest May 27, 2026 2026: Labeling · 2018: Labeling |
| NDA212479 JYLAMVO | Shorla | November 29, 2022 | 3, latest May 27, 2026 2026: Labeling · 2024: Efficacy · 2024: Efficacy |
Generic approvals (21)
- ANDA089340Hikma · September 16, 1986
- ANDA089341Hikma · September 16, 1986
- ANDA089342Hikma · September 16, 1986
- ANDA089343Hikma · September 16, 1986
- ANDA081099Barr · October 15, 1990
- ANDA081235Mylan · May 15, 1992
- ANDA040054Hikma · August 1, 1994
- ANDA040263Fresenius Kabi USA · February 26, 1999
- ANDA040266Fresenius Kabi USA · February 26, 1999
- ANDA040385Barr · March 21, 2001
- ANDA040632Hikma · August 12, 2005
- ANDA040716Accord Hlthcare · April 30, 2007
- ANDA040843Pharmachemie Bv · January 8, 2010
- ANDA201529Eugia Pharma Speclts · March 29, 2012
- ANDA201749Sun Pharm · May 21, 2015
- ANDA207812Zydus Pharms · January 13, 2017
- ANDA213343Accord Hlthcare · January 24, 2020
- ANDA210454Eugia Pharma · January 30, 2020
- ANDA216453Elite Labs Inc · May 16, 2024
- ANDA217552Alembic · June 3, 2024
- ANDA220225Alembic · April 15, 2026
Shortage status
Current shortage · updated October 29, 2026 · first posted March 13, 2023
| Product | Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40) |
|---|---|
| Availability | Available |
| Company | Hospira, Inc., a Pfizer Company |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 22, 2023 · Class III · Ongoing · D-0066-2024
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25 — West-Ward Columbus Inc
-
March 15, 2021 · Class II · Terminated · D-0553-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38. — Cardinal Health Inc.
-
June 27, 2012 · Class II · Terminated · D-1681-2012
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the parti
Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41 — Hospira Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 105585, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595, 311625 … (+10) |
|---|---|
| SPL set ID of the quoted label | d0075461-0e7e-4967-9c9b-d6440e912c0e |
| FDA labels (SPL) | 45 |
| FDA applications | NDA011719, NDA204824, NDA205776, NDA208400, NDA212479, 21 ANDA |
| Active ingredients (FDA) | METHOTREXATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rasuvo, Medexus Pharma Inc., effective December 15, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →