Decitabine
These highlights do not include all the information needed to use DECITABINE FOR INJECTION safely and effectively. See full prescribing information for DECITABINE FOR INJECTION Initial U.S. Approval:2006
Approved
Approval ID
77a7ea8f-3037-4ca6-b605-e5d1df5e7422
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2023
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Decitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-905
Application NumberANDA205539
Product Classification
M
Marketing Category
C73584
G
Generic Name
Decitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (3)
DECITABINEActive
Quantity: 50 mg in 10 mL
Code: 776B62CQ27
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Code: 4J9FJ0HL51
Classification: IACT