NDC 63020-113

Alunbrig

Brigatinib

Alunbrig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Brigatinib.

Product ID63020-113_016a4a8c-c47c-49a2-b38f-439eebc4c466
NDC63020-113
Product TypeHuman Prescription Drug
Proprietary NameAlunbrig
Generic NameBrigatinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-04-28
Marketing CategoryNDA / NDA
Application NumberNDA208772
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameBRIGATINIB
Active Ingredient Strength30 mg/1
Pharm ClassesCytochrome P450 3A Inducers [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63020-113-18

180 TABLET, FILM COATED in 1 BOTTLE (63020-113-18)
Marketing Start Date2017-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63020-113-18 [63020011318]

Alunbrig TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208772
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-02

NDC 63020-113-21 [63020011321]

Alunbrig TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208772
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-02

NDC 63020-113-30 [63020011330]

Alunbrig TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA208772
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-02

Drug Details

Active Ingredients

IngredientStrength
BRIGATINIB30 mg/1

OpenFDA Data

SPL SET ID:0fe9ff20-d402-41f3-bc1e-7002ea7007db
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1921228
  • 1988786
  • 1921222
  • 1988772
  • 1988770
  • 1925494
  • 1988768
  • 1988785
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Tyrosine Kinase Inhibitors [MoA]
    • Cytochrome P450 3A Inducers [MoA]

    NDC Crossover Matching brand name "Alunbrig" or generic name "Brigatinib"

    NDCBrand NameGeneric Name
    63020-090Alunbrigbrigatinib
    63020-113Alunbrigbrigatinib
    63020-180Alunbrigbrigatinib
    63020-198Alunbrigbrigatinib
    76189-113AlunbrigBrigatinib

    Trademark Results [Alunbrig]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALUNBRIG
    ALUNBRIG
    86797024 5251769 Live/Registered
    ARIAD Pharmaceuticals, Inc.
    2015-10-23

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