Allopurinol
ALLOPURINOL TABLETS USP 100 mg and 300 mg Rx Only
Approved
Approval ID
11f1fc6e-b274-4132-9edd-522a819a479b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 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 Code50090-6716
Application NumberANDA204467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2021
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT