NDC 59572-705

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 ID: 59572-705_2cc85163-ed52-43ef-8f2a-d613b9f9573a
• NDC: 59572-705
• Product Type: Human Prescription Drug
• Proprietary Name: Idhifa
• Generic Name: Enasidenib Mesylate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-01
• Marketing Category: NDA / NDA
• Application Number: NDA209606
• Labeler Name: Celgene Corporation
• Substance Name: ENASIDENIB MESYLATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Isocitrate Dehydrogenase 2 Inhibitor [EPC],Isocitrate Dehydrogenase 2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59572-705-30

30 TABLET, FILM COATED in 1 BOTTLE (59572-705-30)

• Marketing Start Date: 2017-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59572-705-30 [59572070530]

Idhifa TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209606
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ENASIDENIB MESYLATE	50 mg/1

OpenFDA Data

• SPL SET ID: a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6
• Manufacturer:
  • Celgene Corporation
• UNII:
  • UF6PC17XAV
• 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"

NDC	Brand Name	Generic Name
59572-705	Idhifa	enasidenib mesylate
59572-710	Idhifa	enasidenib mesylate