Allopurinol
Approved
Approval ID
ae821c68-626a-474c-b81d-ce75d9795b3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code67544-736
Application NumberANDA018659
Product Classification
M
Marketing Category
C73584
G
Generic Name
allopurinol
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2016
FDA Product Classification
INGREDIENTS (7)
ALLOPURINOLActive
Quantity: 100 mg in 1 1
Code: 63CZ7GJN5I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT