NDC 70255-025

BRAFTOVI

Encorafenib

BRAFTOVI is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Array Biopharma Inc.. The primary component is Encorafenib.

Product ID70255-025_026d5ada-5db2-468c-a035-69669558c8b0
NDC70255-025
Product TypeHuman Prescription Drug
Proprietary NameBRAFTOVI
Generic NameEncorafenib
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-06-27
Marketing CategoryNDA / NDA
Application NumberNDA210496
Labeler NameArray BioPharma Inc.
Substance NameENCORAFENIB
Active Ingredient Strength75 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70255-025-01

2 BOTTLE in 1 CARTON (70255-025-01) > 90 CAPSULE in 1 BOTTLE (70255-025-02)
Marketing Start Date2018-06-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70255-025-02 [70255002502]

BRAFTOVI CAPSULE
Marketing CategoryNDA
Application NumberNDA210496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-27

NDC 70255-025-03 [70255002503]

BRAFTOVI CAPSULE
Marketing CategoryNDA
Application NumberNDA210496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-27

NDC 70255-025-04 [70255002504]

BRAFTOVI CAPSULE
Marketing CategoryNDA
Application NumberNDA210496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-09

NDC 70255-025-01 [70255002501]

BRAFTOVI CAPSULE
Marketing CategoryNDA
Application NumberNDA210496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-27

Drug Details

Active Ingredients

IngredientStrength
ENCORAFENIB75 mg/1

OpenFDA Data

SPL SET ID:235dfc38-0f0b-4037-b501-7a9f4294740c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2049121
  • 2049117
  • 2049111
  • 2049119
  • NDC Crossover Matching brand name "BRAFTOVI" or generic name "Encorafenib"

    NDCBrand NameGeneric Name
    70255-020BRAFTOVIEncorafenib
    70255-025BRAFTOVIEncorafenib

    Trademark Results [BRAFTOVI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BRAFTOVI
    BRAFTOVI
    90021001 not registered Live/Pending
    Array BioPharma Inc.
    2020-06-25
    BRAFTOVI
    BRAFTOVI
    87077386 5561579 Live/Registered
    Array Biopharma Inc.
    2016-06-20

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