Idhifa
These highlights do not include all the information needed to use IDHIFA safely and effectively. See full prescribing information for IDHIFA. IDHIFA (enasidenib) tablets, for oral use Initial U.S. Approval: 2017
Approved
Approval ID
a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
Celgene Corporation
DUNS: 174201137
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
enasidenib mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-705
Application NumberNDA209606
Product Classification
M
Marketing Category
C73594
G
Generic Name
enasidenib mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (13)
ENASIDENIB MESYLATEActive
Quantity: 50 mg in 1 1
Code: UF6PC17XAV
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
enasidenib mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-710
Application NumberNDA209606
Product Classification
M
Marketing Category
C73594
G
Generic Name
enasidenib mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2020
FDA Product Classification
INGREDIENTS (13)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ENASIDENIB MESYLATEActive
Quantity: 100 mg in 1 1
Code: UF6PC17XAV
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT