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NDC 50419-395, darolutamide, tablet, film coated, from Bayer HealthCare Pharmaceuticals Inc..

Product NDC
50419-395
Status
Listed
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Dosage form
TABLET, FILM COATED
Route
ORAL
Product type
HUMAN PRESCRIPTION DRUG
Marketing category
NDA
Application
NDA212099
DEA schedule
None
Request
curl https://api.healthcare.dev/v1/drugs/ndc/50419-395 \
  -H "Authorization: Bearer $HDEV_API_KEY"

Product

Active ingredients and packages

Active ingredients

  • DAROLUTAMIDE300 mg/1
Package NDCNDC-11Package
50419-395-01504190395011 BOTTLE in 1 CARTON (50419-395-01) / 120 TABLET, FILM COATED in 1 BOTTLE
50419-395-72504190395721 BOTTLE in 1 CARTON (50419-395-72) / 120 TABLET, FILM COATED in 1 BOTTLE

Linked data

RxNorm, label and prices

RxNorm concepts

Related lookups

  • FDA label sections

    GET /v1/drugs/labels/1a7cb212-56e4-4b9d-a73d-bfee7fe4735e

Use it

Look up 50419-395 from code or an agent

curl
curl https://api.healthcare.dev/v1/drugs/ndc/50419-395 \
  -H "Authorization: Bearer $HDEV_API_KEY"
MCP prompt
Using the healthcare.dev MCP server, look up NDC 50419-395. Tell me the product, its labeler, dosage form and route, its packages, and the RxNorm concepts it maps to.

Source: FDA, release 2026-10-23. Public domain. Reference data, not medical advice.