Allopurinol
PRODUCT INFORMATION Allopurinol Tablets USP 100 mg and 300 mg Tablets
Approved
Approval ID
3bcd1381-34d9-4fa5-bfc5-2566cb7a7638
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 26, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-0467
Application NumberANDA203154
Product Classification
M
Marketing Category
C73584
G
Generic Name
allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB