Quick answers
- What is Jakafi?
- Jakafi is a brand name of Ruxolitinib, a prescription medicine. The FDA NDC Directory lists 5 Jakafi products in 5 strengths and forms.
- Who makes Jakafi?
- Incyte Corp holds the FDA application for Jakafi (NDA202192, approved November 16, 2011).
- Is there a generic or store brand of Jakafi?
- Other products of Ruxolitinib are listed with the FDA, but none in exactly the same strength and form as a Jakafi product.
- Has Jakafi been recalled?
- No recall linked to Jakafi products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Jakafi is
Each Jakafi 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 10 mg tablet (oral) | Jakafi | None listed | DailyMed |
| ruxolitinib 15 mg tablet (oral) | Jakafi | None listed | DailyMed |
| ruxolitinib 20 mg tablet (oral) | Jakafi | None listed | DailyMed |
| ruxolitinib 25 mg tablet (oral) | Jakafi | None listed | DailyMed |
| ruxolitinib 5 mg tablet (oral) | Jakafi | 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 |
|---|---|---|---|
| NDA202192 | Incyte Corp | November 16, 2011 | 5 |
Companies that list Jakafi
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Jakafi products.
- Incyte Corporation5 products
Recalls
No recall linked to Jakafi 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.