hyrnuo

Generic: sevabertinib

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

Drug Facts

Product Profile

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

sevabertinib 10 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-397
Product ID 50419-397_654f8e2c-0b86-4320-b392-81f42fa8cadd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219972
Listing Expiration 2027-12-31
Marketing Start 2025-11-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419397
Hyphenated Format 50419-397

Supplemental Identifiers

RxCUI
2728192 2728198
UNII
2A7VPM5RWH

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 hyrnuo (source: ndc)
Generic Name sevabertinib (source: ndc)
Application Number NDA219972 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)
source: ndc

Packages (1)

50419-397-01 120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)

Ingredients (1)

sevabertinib (10 mg/1)

Linked Drug Pages (1)

HYRNUO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "654f8e2c-0b86-4320-b392-81f42fa8cadd", "openfda": {"unii": ["2A7VPM5RWH"], "rxcui": ["2728192", "2728198"], "spl_set_id": ["d7a11334-6e7a-445b-9a16-bdcd9acbe61f"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)", "package_ndc": "50419-397-01", "marketing_start_date": "20251119"}], "brand_name": "HYRNUO", "product_id": "50419-397_654f8e2c-0b86-4320-b392-81f42fa8cadd", "dosage_form": "TABLET, FILM COATED", "product_ndc": "50419-397", "generic_name": "SEVABERTINIB", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYRNUO", "active_ingredients": [{"name": "SEVABERTINIB", "strength": "10 mg/1"}], "application_number": "NDA219972", "marketing_category": "NDA", "marketing_start_date": "20251119", "listing_expiration_date": "20271231"}