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 ID71777-392_5b9e7961-f843-49d8-94b5-a2ce2c9efa46
NDC71777-392
Product TypeHuman Prescription Drug
Proprietary NameVITRAKVI
Generic NameLarotrectinib
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-11-26
Marketing CategoryNDA / NDA
Application NumberNDA211710
Labeler NameLoxo Oncology, Inc.
Substance NameLAROTRECTINIB
Active Ingredient Strength20 mg/mL
Pharm ClassesKinase Inhibitor [EPC],Tropomyosin Receptor Kinases Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71777-392-01

100 mL in 1 BOTTLE (71777-392-01)
Marketing Start Date2018-11-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71777-392-01 [71777039201]

VITRAKVI SOLUTION
Marketing CategoryNDA
Application NumberNDA211710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-26

Drug Details

Active Ingredients

IngredientStrength
LAROTRECTINIB20 mg/mL

OpenFDA Data

SPL SET ID:9525f887-a055-4e33-8e92-898d42828cd1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2105653
  • 2105633
  • 2105645
  • 2105657
  • 2105649
  • 2105655
  • NDC Crossover Matching brand name "VITRAKVI" or generic name "Larotrectinib"

    NDCBrand NameGeneric Name
    50419-390VITRAKVILAROTRECTINIB
    50419-391VITRAKVILAROTRECTINIB
    50419-392VITRAKVILAROTRECTINIB
    50419-393VITRAKVILAROTRECTINIB
    71777-390VITRAKVILAROTRECTINIB
    71777-391VITRAKVILAROTRECTINIB
    71777-392VITRAKVILAROTRECTINIB

    Trademark Results [VITRAKVI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VITRAKVI
    VITRAKVI
    87819990 5584983 Live/Registered
    Bayer Aktiengesellschaft
    2018-03-05

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