Imatinib Mesylate
These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
86d6a0c6-693b-4c33-bcfc-e174104384c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imatinib Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-203
Application NumberANDA078340
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 400 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
Imatinib Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60687-192
Application NumberANDA078340
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 100 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM