Medicine
Tofacitinib 16.16 mg tablet
Tofacitinib 16.16 mg tablet is a generic prescription medicine for oral use, made by 2 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 Tofacitinib tablets at 20°C to 25°C (68°F to 77°F).
Key facts
- Active ingredient (INN)
- Tofacitinib
- Brand
- Sold under the generic name
- Strength
- 16.16 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 28 tablets, 60 tablets, 180 tablets and 1 more
- Manufacturers
- Concord BiotechIndiaStellon Biotech
- Origin register
- US FDA, United States
- Storage
- Store Tofacitinib tablets at 20°C to 25°C (68°F to 77°F).
- 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
- 1 October 2026
- Identifiers
- RxCUI 1357541, 2048566DailyMed set ID 6c33e5b4-4843-4a80-a4f8-435bfceddc2a, 89eb2ffc-02d9-4b46-b480-e9b10af33027NDC 68254-5012, 85972-122Application ANDA218821
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 |
|---|---|---|---|
| 28 tablet, film coated in 1 bottle | 68254-5012-1 | Concord BiotechIndia | 1 October 2026 |
| 60 tablet, film coated in 1 bottle | 68254-5012-2 | Concord BiotechIndia | 1 October 2026 |
| 180 tablet, film coated in 1 bottle | 68254-5012-3 | Concord BiotechIndia | 1 October 2026 |
| 60 tablet, film coated in 1 bottle | 85972-122-60 | Stellon Biotech | 1 October 2026 |
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 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 Tofacitinib 16.16 mg 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.