Allopurinol
These highlights do not include all the information needed to use allopurinol tablets and safely and effectively. See full prescribing information for allopurinol tablets. Allopurinol Tablets, for oral use Initial U.S. Approval: 1966
Approved
Approval ID
0780dc78-d287-d5db-e063-6294a90aa1dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
Harman Finochem Limited
DUNS: 675487429
Products 2
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 Code82638-113
Application NumberANDA214443
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Allopurinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82638-112
Application NumberANDA214443
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2023
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB