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. DECITABINE for injection, for intravenous use Initial U.S. Approval: 2006
Approved
Approval ID
de303068-589e-4e0a-90ed-e60b2c1a2b56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2025
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
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 Code68001-642
Application NumberANDA215355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Decitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Code: 4J9FJ0HL51
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DECITABINEActive
Quantity: 50 mg in 10 mL
Code: 776B62CQ27
Classification: ACTIB