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
95a1ca8c-9855-4b11-92cd-6fdc144f0d3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Allopurinol
PRODUCT DETAILS
NDC Product Code16714-576
Application NumberANDA204467
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2021
Generic NameAllopurinol
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
Allopurinol
PRODUCT DETAILS
NDC Product Code16714-577
Application NumberANDA204467
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2021
Generic NameAllopurinol
INGREDIENTS (6)
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT