Allopurinol
These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS.ALLOPURINOL tablets, for oral use. Initial U.S. Approval:1966
Approved
Approval ID
2caa5246-9422-4826-b926-a2566506d3eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Allopurinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4663
Application NumberANDA211820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (6)
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT