Medicine
Xatmep 2.5 mg/mL oral solution
Xatmep 2.5 mg/mL oral solution is a prescription medicine containing Methotrexate for oral use, marketed by Azurity Pharmaceuticals, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store XATMEP refrigerated (2°C to 8°C/36°F to 46°F) tightly closed in the…
Key facts
- Active ingredient (INN)
- Methotrexate
- Brand
- Xatmep
- Strength
- 2.5 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 120 mL, 60 mL
- Marketing authorisation holder
- Azurity Pharmaceuticals
- Manufacturer
- Azurity Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store XATMEP refrigerated (2°C to 8°C/36°F to 46°F) tightly closed in the original container prior to dispensing. Once dispensed, patients may store XATMEP either refrigerated (2°C to 8°C/36°F to 46°F) or at room temperature (20°C to 25°C/68°F to 77°F) with excursions permitted to 15°C to 30°C/59°F to 86°F. Avoid freezing and excessive heat. If stored at room temperature, discard after 60 days.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 1 May 2017
- Identifiers
- RxCUI 1921592, 1921598DailyMed set ID aec9984e-34c5-481b-b6bf-9bb5caf1daf8NDC 52652-2001Application NDA208400
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 |
|---|---|---|---|
| 120 mL in 1 bottle | 52652-2001-1 | Azurity Pharmaceuticals | 1 May 2017 |
| 60 mL in 1 bottle | 52652-2001-6 | Azurity Pharmaceuticals | 13 August 2018 |
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 Xatmep 2.5 mg/mL oral solution 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.