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 useInitial U.S. Approval: 2006
Approved
Approval ID
e509b63e-a652-4d59-8d73-4d9be97e800c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2023
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 080579617
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 Code25021-231
Application NumberANDA205539
Product Classification
M
Marketing Category
C73584
G
Generic Name
decitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 14, 2023
FDA Product Classification
INGREDIENTS (4)
decitabineActive
Quantity: 50 mg in 10 mL
Code: 776B62CQ27
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium phosphate, monobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT