Quick answers
- What is Cabometyx?
- Cabometyx is a brand name of Cabozantinib, a prescription medicine. The FDA NDC Directory lists 3 Cabometyx products in 3 strengths and forms.
- Who makes Cabometyx?
- Exelixis Inc holds the FDA application for Cabometyx (NDA208692, approved April 25, 2016).
- Is there a generic or store brand of Cabometyx?
- Other products of Cabozantinib are listed with the FDA, but none in exactly the same strength and form as a Cabometyx product.
- Has Cabometyx been recalled?
- No recall linked to Cabometyx products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Cabometyx is
Each Cabometyx 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.
Cabozantinib · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cabozantinib s-malate 20 mg tablet (oral) | Cabometyx | None listed | DailyMed |
| cabozantinib s-malate 40 mg tablet (oral) | Cabometyx | None listed | DailyMed |
| cabozantinib s-malate 60 mg tablet (oral) | Cabometyx | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Cabozantinib →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA208692 | Exelixis Inc | April 25, 2016 | 3 |
Companies that list Cabometyx
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Cabometyx products.
- Exelixis, Inc.3 products
Recalls
No recall linked to Cabometyx 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.