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
314faacb-45e7-332e-acc7-b9ff5a475b0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2023
Manufacturers
FDA
Dr. Reddy's Laboratories Inc.
DUNS: 802315887
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 Code43598-143
Application NumberANDA207234
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azacitidine
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateAugust 30, 2018
FDA Product Classification
INGREDIENTS (2)
AzacitidineActive
Quantity: 100 mg in 50 mL
Code: M801H13NRU
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT