PURINETHOL
These highlights do not include all the information needed to use PURINETHOL safely and effectively. See full prescribing information for PURINETHOL. PURINETHOL (mercaptopurine) tablets, for oral use Initial U.S. Approval: 1953
Approved
Approval ID
bfb03539-907f-4424-9c88-6a03ed9467e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Stason Pharmaceuticals, Inc.
DUNS: 807437553
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 Code60763-601
Application NumberNDA009053
Product Classification
M
Marketing Category
C73594
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