vitrakvi

Generic: larotrectinib

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

Drug Facts

Product Profile

Brand Name vitrakvi
Generic Name larotrectinib
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
OROPHARYNGEAL
Active Ingredients

larotrectinib 20 mg/mL

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-393
Product ID 50419-393_62bb733b-5dd7-4df1-9682-c401ffa5973f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211710
Listing Expiration 2027-12-31
Marketing Start 2022-12-06

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
tropomyosin receptor kinases inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419393
Hyphenated Format 50419-393

Supplemental Identifiers

RxCUI
2105633 2105645 2105649 2105653 2105655 2105657
UNII
PF9462I9HX
NUI
N0000175605 N0000193859

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 vitrakvi (source: ndc)
Generic Name larotrectinib (source: ndc)
Application Number NDA211710 (source: ndc)
Routes
OROPHARYNGEAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02)
source: ndc

Packages (1)

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

Ingredients (1)

larotrectinib (20 mg/mL)

Linked Drug Pages (1)

VITRAKVI ndc-match (0.9)

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"}