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. AZACITIDINE for injection for subcutaneous or intravenous use Initial U.S. Approval: 2004
Approved
Approval ID
55915b5d-0e85-4ede-ad4f-ac89670d8973
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-3253
Application NumberNDA050794
Product Classification
M
Marketing Category
C73605
G
Generic Name
azacitidine
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateJune 9, 2022
FDA Product Classification
INGREDIENTS (2)
AZACITIDINEActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT