Allopurinol
Approved
Approval ID
994b3117-b83e-44d9-910c-1c3a26ef838e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Mylan Institutional Inc.
DUNS: 039615992
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 Code51079-205
Application NumberANDA018659
Product Classification
M
Marketing Category
C73584
G
Generic Name
allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
allopurinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51079-206
Application NumberANDA018659
Product Classification
M
Marketing Category
C73584
G
Generic Name
allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALLOPURINOLActive
Quantity: 300 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT