NDC 0597-0138

Gilotrif

Afatinib

Gilotrif is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Afatinib.

Product ID0597-0138_256c019d-6658-43f0-8ec5-2dee75f0e92d
NDC0597-0138
Product TypeHuman Prescription Drug
Proprietary NameGilotrif
Generic NameAfatinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-07-12
Marketing CategoryNDA / NDA
Application NumberNDA201292
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameAFATINIB
Active Ingredient Strength40 mg/1
Pharm ClassesKinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0597-0138-30

1 BOTTLE in 1 CARTON (0597-0138-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2013-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0138-30 [00597013830]

Gilotrif TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA201292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-08-08

NDC 0597-0138-95 [00597013895]

Gilotrif TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA201292
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-08-08

Drug Details

Active Ingredients

IngredientStrength
AFATINIB40 mg/1

OpenFDA Data

SPL SET ID:fd638e5e-8032-e7ca-0179-95e96ab5d387
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1430446
  • 1430449
  • 1430457
  • 1430455
  • 1430453
  • 1430451
  • Pharmacological Class

    • Kinase Inhibitor [EPC]
    • Protein Kinase Inhibitors [MoA]

    NDC Crossover Matching brand name "Gilotrif" or generic name "Afatinib"

    NDCBrand NameGeneric Name
    0597-0137Gilotrifafatinib
    0597-0138Gilotrifafatinib
    0597-0141Gilotrifafatinib

    Trademark Results [Gilotrif]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GILOTRIF
    GILOTRIF
    86011486 4470944 Live/Registered
    Boehringer Ingelheim International GmbH
    2013-07-16

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