Imatinib Mesylate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for Initial U.S. Approval: 2001
Approved
Approval ID
a9cfc301-3c7f-4910-8813-41dcb0b4ca69
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-7629
Application NumberANDA204285
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2022
FDA Product Classification
INGREDIENTS (14)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 100 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Imatinib Mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7630
Application NumberANDA204285
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib Mesylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2022
FDA Product Classification
INGREDIENTS (14)
IMATINIB MESYLATEActive
Quantity: 400 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT