Package 50419-390-01

Brand: vitrakvi

Generic: larotrectinib
NDC Package

Package Facts

Identity

Package NDC 50419-390-01
Digits Only 5041939001
Product NDC 50419-390
Description

60 CAPSULE in 1 BOTTLE (50419-390-01)

Marketing

Marketing Status
Marketed Since 2019-07-26
Brand vitrakvi
Generic larotrectinib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "62bb733b-5dd7-4df1-9682-c401ffa5973f", "openfda": {"nui": ["N0000175605", "N0000193859"], "unii": ["PF9462I9HX"], "rxcui": ["2105633", "2105645", "2105649", "2105653", "2105655", "2105657"], "spl_set_id": ["0c8ca614-58b2-4aa4-83d3-0387a8f782fd"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Tropomyosin Receptor Kinases Inhibitors [MoA]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (50419-390-01)", "package_ndc": "50419-390-01", "marketing_start_date": "20190726"}], "brand_name": "VITRAKVI", "product_id": "50419-390_62bb733b-5dd7-4df1-9682-c401ffa5973f", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Tropomyosin Receptor Kinases Inhibitors [MoA]"], "product_ndc": "50419-390", "generic_name": "LAROTRECTINIB", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VITRAKVI", "active_ingredients": [{"name": "LAROTRECTINIB", "strength": "25 mg/1"}], "application_number": "NDA210861", "marketing_category": "NDA", "marketing_start_date": "20190726", "listing_expiration_date": "20271231"}