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
a4e409f7-20b4-4c80-8a6a-f95995ffad78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code59651-241
Application NumberANDA212773
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (11)
IMATINIB MESYLATEActive
Quantity: 400 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MICROCRYSTALLINE CELLULOSE 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Imatinib Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-240
Application NumberANDA212773
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 5, 2022
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 100 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
MICROCRYSTALLINE CELLULOSE 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT