nubeqa

Generic: darolutamide

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nubeqa
Generic Name darolutamide
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

darolutamide 300 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-395
Product ID 50419-395_f29fbb0a-49ef-488f-b34f-1420e473e20c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212099
Listing Expiration 2027-12-31
Marketing Start 2019-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419395
Hyphenated Format 50419-395

Supplemental Identifiers

RxCUI
2180330 2180336
UNII
X05U0N2RCO

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nubeqa (source: ndc)
Generic Name darolutamide (source: ndc)
Application Number NDA212099 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

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

Ingredients (1)

darolutamide (300 mg/1)

Linked Drug Pages (1)

NUBEQA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f29fbb0a-49ef-488f-b34f-1420e473e20c", "openfda": {"unii": ["X05U0N2RCO"], "rxcui": ["2180330", "2180336"], "spl_set_id": ["1a7cb212-56e4-4b9d-a73d-bfee7fe4735e"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50419-395-01)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50419-395-01", "marketing_start_date": "20190731"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50419-395-72)  / 120 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50419-395-72", "marketing_start_date": "20210303"}], "brand_name": "NUBEQA", "product_id": "50419-395_f29fbb0a-49ef-488f-b34f-1420e473e20c", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50419-395", "generic_name": "darolutamide", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NUBEQA", "active_ingredients": [{"name": "DAROLUTAMIDE", "strength": "300 mg/1"}], "application_number": "NDA212099", "marketing_category": "NDA", "marketing_start_date": "20190731", "listing_expiration_date": "20271231"}