NDC 50419-395

NUBEQA

Darolutamide

NUBEQA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Darolutamide.

• Product ID: 50419-395_229c2bdc-61a2-4e84-b12c-3b73f61b2ae7
• NDC: 50419-395
• Product Type: Human Prescription Drug
• Proprietary Name: NUBEQA
• Generic Name: Darolutamide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-31
• Marketing Category: NDA / NDA
• Application Number: NDA212099
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: DAROLUTAMIDE
• Active Ingredient Strength: 300 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50419-395-01

1 BOTTLE in 1 CARTON (50419-395-01) > 120 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2019-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-395-01 [50419039501]

NUBEQA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA212099
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-07-31

Drug Details

Active Ingredients

Ingredient	Strength
DAROLUTAMIDE	300 mg/1

OpenFDA Data

• SPL SET ID: 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • X05U0N2RCO
• RxNorm Concept Unique ID - RxCUI:
  • 2180336
  • 2180330