Allopurinol
Allopurinol Tablets, USP 8467701/0322 Rx Only
Approved
Approval ID
f6f7642b-5046-47d6-b259-0c9f8aed3b34
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code60687-688
Application NumberANDA211820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Allopurinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-677
Application NumberANDA211820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB