NDC 50419-391

VITRAKVI

Larotrectinib

VITRAKVI is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Larotrectinib.

Product ID50419-391_257059c9-5fa8-4a5c-ae92-4462de9e8ec8
NDC50419-391
Product TypeHuman Prescription Drug
Proprietary NameVITRAKVI
Generic NameLarotrectinib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-07-26
Marketing CategoryNDA / NDA
Application NumberNDA210861
Labeler NameBayer HealthCare Pharmaceuticals Inc.
Substance NameLAROTRECTINIB
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC], Tropomyosin Receptor Kinases Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50419-391-01

60 CAPSULE in 1 BOTTLE (50419-391-01)
Marketing Start Date2019-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50419-391-01 [50419039101]

VITRAKVI CAPSULE
Marketing CategoryNDA
Application NumberNDA210861
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-26

Drug Details

Active Ingredients

IngredientStrength
LAROTRECTINIB100 mg/1

OpenFDA Data

SPL SET ID:0c8ca614-58b2-4aa4-83d3-0387a8f782fd
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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