NUBEQA
Active substance: darolutamide
TABLET, FILM COATED · DAROLUTAMIDE 300 mg/1
United StatesActive
Marketing holder: Bayer HealthCare Pharmaceuticals Inc.
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- DAROLUTAMIDE · 300 mg/1
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a12096-0412-7542-bd1c-c9ac919766f1;count=1 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 50419-395
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 50419-395 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 50419-395 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 50419-395 · Verified 2026-10-09 · open in source