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
f02c9bef-e47f-4b70-95f6-9341d87346ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-365
Application NumberANDA215765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azacitidine
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
AZACITIDINEActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB