Package 50419-393-03

Brand: vitrakvi

Generic: larotrectinib
NDC Package

Package Facts

Identity

Package NDC 50419-393-03
Digits Only 5041939303
Product NDC 50419-393
Product ID 50419-393_62bb733b-5dd7-4df1-9682-c401ffa5973f
Description

2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02)

Marketing

Marketing Status
Marketed Since 2022-12-06
Brand vitrakvi
Generic larotrectinib
Sample Package No

Linked Drug Pages (1)

VITRAKVI ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OROPHARYNGEAL"], "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": "2 BOTTLE in 1 CARTON (50419-393-03)  / 50 mL in 1 BOTTLE (50419-393-02)", "package_ndc": "50419-393-03", "marketing_start_date": "20221206"}], "brand_name": "VITRAKVI", "product_id": "50419-393_62bb733b-5dd7-4df1-9682-c401ffa5973f", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Kinase Inhibitor [EPC]", "Tropomyosin Receptor Kinases Inhibitors [MoA]"], "product_ndc": "50419-393", "generic_name": "LAROTRECTINIB", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VITRAKVI", "active_ingredients": [{"name": "LAROTRECTINIB", "strength": "20 mg/mL"}], "application_number": "NDA211710", "marketing_category": "NDA", "marketing_start_date": "20221206", "listing_expiration_date": "20271231"}