Package 50419-397-01

Brand: hyrnuo

Generic: sevabertinib
NDC Package

Package Facts

Identity

Package NDC 50419-397-01
Digits Only 5041939701
Product NDC 50419-397
Product ID 50419-397_654f8e2c-0b86-4320-b392-81f42fa8cadd
Description

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

Marketing

Marketing Status
Marketed Since 2025-11-19
Brand hyrnuo
Generic sevabertinib
Sample Package No

Linked Drug Pages (1)

HYRNUO ndc-match (0.95)

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"}