Mercaptopurine
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 useInitial U.S. Approval: 1953
Approved
Approval ID
c3b5b8b0-bc5c-4ce9-bbdc-febba60c2658
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 21, 2021
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
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 Code0054-4581
Application NumberANDA040528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mercaptopurine
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2018
FDA Product Classification
INGREDIENTS (10)
MERCAPTOPURINEActive
Quantity: 50 mg in 1 1
Code: E7WED276I5
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT