Medicine
Xeljanz XR 11 mg extended-release tablet
Xeljanz XR 11 mg extended-release tablet is a prescription medicine containing Tofacitinib for oral use, marketed by Pfizer Laboratories, 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 XELJANZ tablets and XELJANZ XR at 20°C to 25°C (68°F to 77°F). Storage…
Key facts
- Active ingredient (INN)
- Tofacitinib
- Brand
- Xeljanz XR
- Strength
- 11 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturers
- Pfizer LaboratoriesUS Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store XELJANZ tablets and XELJANZ XR at 20°C to 25°C (68°F to 77°F). Storage and Handling for XELJANZ Oral Solution Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Store in the original bottle and carton to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AF01 Tofacitinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 7 March 2016
- Identifiers
- RxCUI 1357541, 1357547, 1741046 +7DailyMed set ID cf74ba2f-afc5-4baa-8594-979c889a5831, 68e3d6b2-7838-4d2d-a417-09d919b43e13NDC 0069-0501, 63539-501Application NDA208246
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 |
|---|---|---|---|
| 30 tablet, film coated, extended release in 1 bottle | 0069-0501-30 | Pfizer Laboratories | 7 March 2016 |
| 30 tablet, extended release in 1 bottle | 63539-501-30 | US Pharmaceuticals | 7 March 2016 |
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 Tofacitinib 11 mg extended-release tablet.
Other strengths and forms of Tofacitinib
Clinical summary
Tofacitinib is a janus kinase inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. MedsAcross supplies Tofacitinib 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 TofacitinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XELJANZ prescribing information (US Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Xeljanz: European public assessment report (EPAR) · European Medicines Agency
Need Xeljanz XR 11 mg extended-release tablet 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.