NDC 71777-392

VITRAKVI

Larotrectinib

VITRAKVI is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Loxo Oncology, Inc.. The primary component is Larotrectinib.

• Product ID: 71777-392_5b9e7961-f843-49d8-94b5-a2ce2c9efa46
• NDC: 71777-392
• Product Type: Human Prescription Drug
• Proprietary Name: VITRAKVI
• Generic Name: Larotrectinib
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-26
• Marketing Category: NDA / NDA
• Application Number: NDA211710
• Labeler Name: Loxo Oncology, 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: 2020-12-31

Packaging

NDC 71777-392-01

100 mL in 1 BOTTLE (71777-392-01)

• Marketing Start Date: 2018-11-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71777-392-01 [71777039201]

VITRAKVI SOLUTION

• Marketing Category: NDA
• Application Number: NDA211710
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-26

Drug Details

Active Ingredients

Ingredient	Strength
LAROTRECTINIB	20 mg/mL

OpenFDA Data

• SPL SET ID: 9525f887-a055-4e33-8e92-898d42828cd1
• Manufacturer:
  • Loxo Oncology, 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