NDC 50419-392

VITRAKVI

Larotrectinib

VITRAKVI is a Oropharyngeal Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Larotrectinib.

• Product ID: 50419-392_257059c9-5fa8-4a5c-ae92-4462de9e8ec8
• NDC: 50419-392
• Product Type: Human Prescription Drug
• Proprietary Name: VITRAKVI
• Generic Name: Larotrectinib
• Dosage Form: Solution, Concentrate
• Route of Administration: OROPHARYNGEAL
• Marketing Start Date: 2019-07-26
• Marketing Category: NDA / NDA
• Application Number: NDA211710
• Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
• Substance Name: LAROTRECTINIB
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Kinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50419-392-01

100 mL in 1 BOTTLE (50419-392-01)

• Marketing Start Date: 2019-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50419-392-01 [50419039201]

VITRAKVI SOLUTION, CONCENTRATE

• Marketing Category: NDA
• Application Number: NDA211710
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-07-26

Drug Details

Active Ingredients

Ingredient	Strength
LAROTRECTINIB	20 mg/mL

OpenFDA Data

• SPL SET ID: 0c8ca614-58b2-4aa4-83d3-0387a8f782fd
• Manufacturer:
  • Bayer HealthCare Pharmaceuticals Inc.
• UNII:
  • PF9462I9HX
• RxNorm Concept Unique ID - RxCUI:
  • 2105653
  • 2105633
  • 2105645
  • 2105657
  • 2105649
  • 2105655

NDC Crossover Matching brand name "VITRAKVI" or generic name "Larotrectinib"

NDC	Brand Name	Generic Name
50419-390	VITRAKVI	LAROTRECTINIB
50419-391	VITRAKVI	LAROTRECTINIB
50419-392	VITRAKVI	LAROTRECTINIB
50419-393	VITRAKVI	LAROTRECTINIB
71777-390	VITRAKVI	LAROTRECTINIB
71777-391	VITRAKVI	LAROTRECTINIB
71777-392	VITRAKVI	LAROTRECTINIB