50419-395 : Nubeqa 300 mg Oral Tablet, Film Coated


NDC50419-395
Labeler: Bayer Healthcare Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Nubeqa
Dosage Form: Oral Tablet, Film Coated
Application #: NDA212099
Rev. Date: 


Appearance:


Markings: 300;Bayer
Shapes:  Oval
Colors:  White
Size (mm): 16
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 50419-395-01: 1 BOTTLE IN 1 CARTON (50419‑395‑01) > 120 TABLET, FILM COATED IN 1 BOTTLE
  • 50419-395-72: 1 BOTTLE IN 1 CARTON (50419‑395‑72) > 120 TABLET, FILM COATED IN 1 BOTTLE

Active Ingredients:

  • Darolutamide

Dosage Strength:

  • 300 mg

Inactive Ingredients:

  • Anhydrous Dibasic Calcium Phosphate
  • Croscarmellose Sodium
  • Lactose Monohydrate
  • Magnesium Stearate
  • Povidone K30
  • Polyethylene Glycol 3350
  • Titanium Dioxide /

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.