# NUBEQA

NDC: 50419-395
Generic name: darolutamide
Labeler / Manufacturer: Bayer HealthCare Pharmaceuticals Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: TABLET, FILM COATED
Routes: ORAL
Marketing started: 20190731

FDA application: NDA212099

## Active ingredients

- DAROLUTAMIDE: 300 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"50419-395"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=50419-395
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1a7cb212-56e4-4b9d-a73d-bfee7fe4735e