idhifa

Generic: enasidenib mesylate

Labeler: celgene corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name idhifa
Generic Name enasidenib mesylate
Labeler celgene corporation
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

enasidenib mesylate 100 mg/1

Manufacturer
Celgene Corporation

Identifiers & Regulatory

Product NDC 59572-710
Product ID 59572-710_32634006-49db-4043-b84b-65f7f54b142d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209606
Listing Expiration 2026-12-31
Marketing Start 2017-08-01

Pharmacologic Class

Classes
isocitrate dehydrogenase 2 inhibitor [epc] isocitrate dehydrogenase 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59572710
Hyphenated Format 59572-710

Supplemental Identifiers

RxCUI
1940370 1940372 1940374 1940376
UNII
UF6PC17XAV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name idhifa (source: ndc)
Generic Name enasidenib mesylate (source: ndc)
Application Number NDA209606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30)
source: ndc

Packages (1)

59572-710-30 30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30)

Ingredients (1)

enasidenib mesylate (100 mg/1)

Linked Drug Pages (1)

Idhifa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32634006-49db-4043-b84b-65f7f54b142d", "openfda": {"unii": ["UF6PC17XAV"], "rxcui": ["1940370", "1940372", "1940374", "1940376"], "spl_set_id": ["a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6"], "manufacturer_name": ["Celgene Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30)", "package_ndc": "59572-710-30", "marketing_start_date": "20170801"}], "brand_name": "Idhifa", "product_id": "59572-710_32634006-49db-4043-b84b-65f7f54b142d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Isocitrate Dehydrogenase 2 Inhibitor [EPC]", "Isocitrate Dehydrogenase 2 Inhibitors [MoA]"], "product_ndc": "59572-710", "generic_name": "enasidenib mesylate", "labeler_name": "Celgene Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Idhifa", "active_ingredients": [{"name": "ENASIDENIB MESYLATE", "strength": "100 mg/1"}], "application_number": "NDA209606", "marketing_category": "NDA", "marketing_start_date": "20170801", "listing_expiration_date": "20261231"}