Medicine
Methotrexate 50 mg/2 mL injection
Methotrexate 50 mg/2 mL injection is a generic prescription medicine for intra-arterial, intramuscular, intrathecal, intravenous use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT.
Key facts
- Active ingredient (INN)
- Methotrexate
- Brand
- Sold under the generic name
- Strength
- 50 mg/2 mL
- Dosage form
- Injection
- Route
- Intra-arterial, intramuscular, intrathecal, intravenous
- Packs
- 1 vial of 2 mL, 10 vials of 2 mL
- Manufacturers
- Accord HealthcareIndiaHikma PharmaceuticalsTeva Parenteral Medicines
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). PROTECT FROM LIGHT.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BA01 Methotrexate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 July 2012
- Identifiers
- RxCUI 1655956, 1655959, 1655960 +2DailyMed set ID 346ec9ce-dc98-4a55-b55e-d3af11f2d703, dd035a9f-cd40-4314-b9d8-2294b8a924e2, 3989d30d-56e5-4e8d-9379-c30fecc894f2NDC 0703-3671, 16729-277, 0143-9519Application ANDA040843, ANDA040716, ANDA089340
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial in 1 carton / 2 mL in 1 vial | 16729-277-30 | Accord HealthcareIndia | 7 March 2014 |
| 10 vial in 1 carton / 2 mL in 1 vial | 0143-9519-10 | Hikma Pharmaceuticals | 10 October 2017 |
| 1 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0703-3671-01 | Teva Parenteral Medicines | 8 June 2018 |
| 1 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 55150-510-01 | — | 11 September 2024 |
| 5 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 55150-510-05 | — | 11 September 2024 |
| 5 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 61703-161-05 | — | 4 November 2024 |
| 5 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 46708-711-05 | — | 15 April 2026 |
| 5 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 62332-711-05 | — | 15 April 2026 |
| 5 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 61703-350-10 | — | 25 September 2014 |
| 5 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 61703-350-38 | — | 27 July 2005 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Methotrexate 50 mg/2 mL injection.
Other strengths and forms of Methotrexate
Clinical summary
Methotrexate is a folate analog metabolic inhibitor indicated for neoplastic diseases for the, among other approved uses. It is available as injection, tablets and powder for injection for oral, subcutaneous and intramuscular use. MedsAcross supplies Methotrexate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MethotrexateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Methotrexate prescribing information (Hospira) · U.S. National Library of Medicine, DailyMed
- Jylamvo: European public assessment report (EPAR) · European Medicines Agency
- Nordimet: European public assessment report (EPAR) · European Medicines Agency
Need Methotrexate 50 mg/2 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.