Mercaptopurine
Mercaptopurine Tablets 50 mg HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Mercaptopurine Tablets safely and effectively. See full prescribing information for Mercaptopurine Tablets. Mercaptopurine tablets, for oral use Initial U.S. Approval: 1953
Approved
Approval ID
9001c081-f455-4fb0-aef0-175d41810c12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Quinn Pharmaceuticals
DUNS: 084014259
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 Code69076-913
Application NumberNDA009053
Product Classification
M
Marketing Category
C73605
G
Generic Name
Mercaptopurine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MERCAPTOPURINEActive
Quantity: 50 mg in 1 1
Code: E7WED276I5
Classification: ACTIB