INQOVI
These highlights do not include all the information needed to use INQOVI safely and effectively. See full prescribing information for INQOVI. INQOVI (decitabine and cedazuridine) tablets, for oral useInitial U.S. Approval: 2020
Approved
Approval ID
91a0f80b-f865-4d06-a40d-4d148d99ee71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2022
Manufacturers
FDA
Taiho Pharmaceutical Co., Ltd.
DUNS: 690548730
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CEDAZURIDINE and DECITABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64842-0727
Application NumberNDA212576
Product Classification
M
Marketing Category
C73594
G
Generic Name
CEDAZURIDINE and DECITABINE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2022
FDA Product Classification
INGREDIENTS (12)
CEDAZURIDINEActive
Quantity: 100 mg in 1 1
Code: 39IS23Q1EW
Classification: ACTIB
DECITABINEActive
Quantity: 35 mg in 1 1
Code: 776B62CQ27
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT