ONUREG
These highlights do not include all the information needed to use ONUREG safely and effectively. See full prescribing information for ONUREG. ONUREG (azacitidine) tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
0e95e33f-8aba-4f19-b332-2416580d358b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 26, 2022
Manufacturers
FDA
Celgene Corporation
DUNS: 174201137
Products 2
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 Code59572-730
Application NumberNDA214120
Product Classification
M
Marketing Category
C73594
G
Generic Name
azacitidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2022
FDA Product Classification
INGREDIENTS (5)
AZACITIDINEActive
Quantity: 200 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
azacitidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59572-740
Application NumberNDA214120
Product Classification
M
Marketing Category
C73594
G
Generic Name
azacitidine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2022
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
AZACITIDINEActive
Quantity: 300 mg in 1 1
Code: M801H13NRU
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT