NDC 50419-395
Nubeqa 300 mg tablet, film coated
On the label: Bayer HealthCare Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fermion Oy | Hanko Pohjoinen, Finland | Makes the active ingredient and tests it | Problems found, fixed voluntarilyMar 14, 2024 · 6 inspections |
| Orion Corporation, Orion Pharma | Espoo, Finland | Makes it and tests it | Problems found, fixed voluntarilyNov 7, 2024 · 8 inspections |
| Fermion Oy | Oulu, Finland | Tests it | No problems foundJan 31, 2023 · 6 inspections |
| Orion Corporation, Orion Pharma | Turku, Finland | Tests it | Problems found, fixed voluntarilyApr 25, 2024 · 8 inspections |
| Orion Corporation, Orion Pharma | Salo, Finland | Packages it and labels it | Problems found, fixed voluntarilyOct 25, 2023 · 2 inspections |
| Quinta-Analytica s.r.o. | Prague 10, Czech Republic | Tests it | Problems found, fixed voluntarilyMar 6, 2025 · 8 inspections |
| Sharp Packaging Services, LLC | Allentown, PA, United States | Packages it and labels it | No problems foundNov 21, 2025 · 7 inspections |
Product details
- Generic drug
- Darolutamide: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 300 mg
- Approval
- NDA NDA212099
- On the market since
- Jul 31, 2019
- Package NDCs
50419-395-0150419-395-72- Official label
- DailyMed (National Library of Medicine), updated Sep 28, 2026
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