Active ingredient
Enzalutamide
5 finished FDA listings contain Enzalutamide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ENZALUTAMIDE
- Dosage forms
- Capsule, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 40 mg/1 · 80 mg/1
- Brand names in FDA listings
- Xtandi
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1307298
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 203415 | ASTELLAS | 2012-08-31 | 2 |
| NDA 213674 | ASTELLAS | 2020-08-04 | 3 |
Official labeling on DailyMed
- XTANDI (ENZALUTAMIDE) CAPSULE XTANDI (ENZALUTAMIDE) TABLET [ASTELLAS PHARMA US, INC.] · version 24 · 2026-08-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.