Allopurinol
Allopurinol Tablets USP
Approved
Approval ID
8c0f5af5-a453-4641-933f-ccb2625fca39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-6572
Application NumberANDA075798
Product Classification
M
Marketing Category
C73584
G
Generic Name
allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT