Mercaptopurine
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1953
Approved
Approval ID
15904472-4c32-4224-95d3-eb131a7ff9c8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2022
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mercaptopurine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3547
Application NumberANDA040594
Product Classification
M
Marketing Category
C73584
G
Generic Name
mercaptopurine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2022
FDA Product Classification
INGREDIENTS (5)
MERCAPTOPURINEActive
Quantity: 50 mg in 1 1
Code: E7WED276I5
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT