NDC 69656-102

Varubi

Rolapitant

Varubi is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Tesaro, Inc.. The primary component is Rolapitant.

Product ID69656-102_4e6fc087-797c-49a6-905a-dcf658d60aa5
NDC69656-102
Product TypeHuman Prescription Drug
Proprietary NameVarubi
Generic NameRolapitant
Dosage FormInjection, Emulsion
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-10-25
Marketing CategoryNDA / NDA
Application NumberNDA208399
Labeler NameTesaro, Inc.
Substance NameROLAPITANT
Active Ingredient Strength2 mg/mL
Pharm ClassesNeurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69656-102-10

1 VIAL, SINGLE-DOSE in 1 CARTON (69656-102-10) > 92.5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69656-102-10 [69656010210]

Varubi INJECTION, EMULSION
Marketing CategoryNDA
Application NumberNDA208399
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-25

Drug Details

Active Ingredients

IngredientStrength
ROLAPITANT1.8 mg/mL

OpenFDA Data

SPL SET ID:ed3ef3f8-8cb7-40db-9d75-e728ee607760
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1986889
  • 1665503
  • 1986885
  • 1673373
  • Pharmacological Class

    • Neurokinin 1 Antagonists [MoA]
    • Substance P/Neurokinin-1 Receptor Antagonist [EPC]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Neurokinin 1 Antagonists [MoA]
    • Substance P/Neurokinin-1 Receptor Antagonist [EPC]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "Varubi" or generic name "Rolapitant"

    NDCBrand NameGeneric Name
    69656-101Varubirolapitant
    69656-102Varubirolapitant
    70720-101Varubirolapitant

    Trademark Results [Varubi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VARUBI
    VARUBI
    86591285 4893721 Live/Registered
    Tesaro, Inc.
    2015-04-08

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