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
3b594aba-e798-4105-b801-0b0d970747c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-771
Application NumberANDA207518
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azacitidine
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateSeptember 30, 2018
FDA Product Classification
INGREDIENTS (2)
AZACITIDINEActive
Quantity: 100 mg in 30 mL
Code: M801H13NRU
Classification: ACTIB
MANNITOLInactive
Quantity: 100 mg in 30 mL
Code: 3OWL53L36A
Classification: IACT