Medicine
Opzelura 1.5% cream
Opzelura 1.5% cream is a prescription medicine containing Ruxolitinib for topical use, marketed by Incyte, 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 OPZELURA at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted from 15ºC…
Key facts
- Active ingredient (INN)
- Ruxolitinib
- Brand
- Opzelura
- Strength
- 1.5%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube
- Marketing authorisation holder
- Incyte
- Manufacturer
- Incyte
- Origin register
- US FDA, United States
- Storage
- Store OPZELURA at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted from 15ºC to 30ºC (59ºF to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D11AH09 Ruxolitinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 September 2021
- Identifiers
- RxCUI 2570752, 2570757DailyMed set ID 24da5509-6631-4795-9d42-273faecd08e7NDC 50881-007Application NDA215309
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
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 Ruxolitinib
Clinical summary
Ruxolitinib is a janus kinase inhibitor indicated for treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults, among other approved uses. MedsAcross supplies Ruxolitinib 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 RuxolitinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- JAKAFI prescribing information (Incyte) · U.S. National Library of Medicine, DailyMed
- Jakavi: European public assessment report (EPAR) · European Medicines Agency
- Opzelura: European public assessment report (EPAR) · European Medicines Agency
Need Opzelura 1.5% cream 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.