NDC 59572-710

Idhifa

Enasidenib Mesylate

Idhifa is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Celgene Corporation. The primary component is Enasidenib Mesylate.

Product ID59572-710_2cc85163-ed52-43ef-8f2a-d613b9f9573a
NDC59572-710
Product TypeHuman Prescription Drug
Proprietary NameIdhifa
Generic NameEnasidenib Mesylate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-08-01
Marketing CategoryNDA / NDA
Application NumberNDA209606
Labeler NameCelgene Corporation
Substance NameENASIDENIB MESYLATE
Active Ingredient Strength100 mg/1
Pharm ClassesIsocitrate Dehydrogenase 2 Inhibitor [EPC],Isocitrate Dehydrogenase 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59572-710-30

30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30)
Marketing Start Date2017-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59572-710-30 [59572071030]

Idhifa TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA209606
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-01

Drug Details

Active Ingredients

IngredientStrength
ENASIDENIB MESYLATE100 mg/1

OpenFDA Data

SPL SET ID:a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1940372
  • 1940370
  • 1940376
  • 1940374
  • UPC Code
  • 0359572710306
  • 0359572705302
  • Pharmacological Class

    • Isocitrate Dehydrogenase 2 Inhibitor [EPC]
    • Isocitrate Dehydrogenase 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Idhifa" or generic name "Enasidenib Mesylate"

    NDCBrand NameGeneric Name
    59572-705Idhifaenasidenib mesylate
    59572-710Idhifaenasidenib mesylate

    Trademark Results [Idhifa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IDHIFA
    IDHIFA
    87024412 5244018 Live/Registered
    Celgene Corporation
    2016-05-04

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