Active ingredient
Ruxolitinib
11 finished FDA listings contain Ruxolitinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RUXOLITINIB, RUXOLITINIB PHOSPHATE
- Dosage forms
- Cream, Tablet, Tablet, Extended Release
- Routes
- Oral, Topical
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 11 mg/1 · 15 mg/1 · 15 mg/g · 20 mg/1 · 22 mg/1 · 25 mg/1 · 33 mg/1 · 44 mg/1 · 5 mg/1 · 55 mg/1
- Brand names in FDA listings
- Jakafi, Jakafi Xr, Opzelura
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1193326
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202192 | INCYTE CORP | 2011-11-16 | 5 |
| NDA 215309 | INCYTE CORP | 2021-09-21 | 1 |
| NDA 217180 | INCYTE CORP | 2026-05-01 | 5 |
Official labeling on DailyMed
- JAKAFI (RUXOLITINIB) TABLET JAKAFI XR (RUXOLITINIB) TABLET, EXTENDED RELEASE [INCYTE CORPORATION] · version 42 · 2026-08-03
- OPZELURA (RUXOLITINIB) CREAM [INCYTE CORPORATION] · version 14 · 2026-07-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.