Dacogen
These highlights do not include all the information needed to use DACOGEN safely and effectively. See full prescribing information for DACOGEN. DACOGEN (decitabine) for injection, for intravenous use Initial U.S. Approval: 2006
Approved
Approval ID
deb4a13c-855b-4372-9778-6e81da598df6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Otsuka America Pharmaceutical, Inc.
DUNS: 008314390
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
decitabine
PRODUCT DETAILS
NDC Product Code59148-046
Application NumberNDA021790
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateNovember 11, 2021
Generic Namedecitabine
INGREDIENTS (3)
MONOBASIC POTASSIUM PHOSPHATEInactive
Code: 4J9FJ0HL51
Classification: IACT
DECITABINEActive
Quantity: 50 mg in 20 mL
Code: 776B62CQ27
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT