Medicine
Otrexup 25 mg/0.4 mL injection
Otrexup 25 mg/0.4 mL injection is a prescription medicine containing Methotrexate for subcutaneous use, marketed by Antares Pharma, 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 controlled room temperature, 25°C (77°F), excursions permitted to 15°…
Key facts
- Active ingredient (INN)
- Methotrexate
- Brand
- Otrexup
- Strength
- 25 mg/0.4 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.4 mL, 4 syringes of 0.4 mL
- Marketing authorisation holder
- Antares Pharma
- Manufacturer
- Antares Pharma
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature, 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°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
- 11 October 2013
- Identifiers
- RxCUI 1441402, 1441407, 1441411 +7DailyMed set ID 9ab8ce16-f7de-41d4-a4c8-1c742621b6d5NDC 54436-025Application NDA204824
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 syringe in 1 carton / .4 mL in 1 syringe | 54436-025-01 | Antares Pharma | 11 October 2013 |
| 4 syringe in 1 carton / .4 mL in 1 syringe | 54436-025-04 | Antares Pharma | 11 October 2013 |
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
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 Otrexup 25 mg/0.4 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.