Azacitidine
These highlights do not include all the information needed to use AZACITIDINE FOR INJECTION safely and effectively. See full prescribing information for . AZACITIDINE for injection, Initial U.S. Approval: 2004
Approved
Approval ID
81366ec1-9689-4857-ded6-3d6342fe5132
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azacitidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16714-927
Application NumberANDA201537
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azacitidine
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (2)
AzacitidineActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT