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
70140e11-33f1-2240-e053-2991aa0a0480
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-306
Application NumberANDA207475
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azacitidine
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 4, 2024
FDA Product Classification
INGREDIENTS (2)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
AZACITIDINEActive
Quantity: 100 mg in 1 1
Code: M801H13NRU
Classification: ACTIB