Quick answers
- What is Jakafi XR?
- Jakafi XR is a brand name of Ruxolitinib, a prescription medicine. The FDA NDC Directory lists 5 Jakafi XR products in 5 strengths and forms.
- Who makes Jakafi XR?
- Incyte Corp holds the FDA application for Jakafi XR (NDA217180, approved May 1, 2026).
- Is there a generic or store brand of Jakafi XR?
- Other products of Ruxolitinib are listed with the FDA, but none in exactly the same strength and form as a Jakafi XR product.
- Has Jakafi XR been recalled?
- No recall linked to Jakafi XR products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Jakafi XR is
Each Jakafi XR product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Ruxolitinib · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ruxolitinib 11 mg tablet, extended release (oral) | Jakafi XR | None listed | DailyMed |
| ruxolitinib 22 mg tablet, extended release (oral) | Jakafi XR | None listed | DailyMed |
| ruxolitinib 33 mg tablet, extended release (oral) | Jakafi XR | None listed | DailyMed |
| ruxolitinib 44 mg tablet, extended release (oral) | Jakafi XR | None listed | DailyMed |
| ruxolitinib 55 mg tablet, extended release (oral) | Jakafi XR | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Ruxolitinib →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA217180 | Incyte Corp | May 1, 2026 | 5 |
Companies that list Jakafi XR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Jakafi XR products.
- Incyte Corporation5 products
Recalls
No recall linked to Jakafi XR products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.