LONSURF
These highlights do not include all the information needed to use LONSURF safely and effectively. See full prescribing information for LONSURF. LONSURF (trifluridine and tipiracil) tablets, for oral use Initial U.S. Approval: 2015
Approved
Approval ID
f5beed22-d71d-4c0d-8dca-2c7317d65d85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2023
Manufacturers
FDA
Taiho Pharmaceutical Co., Ltd.
DUNS: 690548730
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
trifluridine and tipiracil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64842-1025
Application NumberNDA207981
Product Classification
M
Marketing Category
C73594
G
Generic Name
trifluridine and tipiracil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 8, 2023
FDA Product Classification
INGREDIENTS (11)
TRIFLURIDINEActive
Quantity: 15 mg in 1 1
Code: RMW9V5RW38
Classification: ACTIB
TIPIRACIL HYDROCHLORIDEActive
Quantity: 6.14 mg in 1 1
Code: 4H59KLQ0A4
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Quantity: 90.735 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Quantity: 1.200 mg in 1 1
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Quantity: 6.000 mg in 1 1
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Quantity: 2.100 mg in 1 1
Code: 3NXW29V3WO
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 0.003 mg in 1 1
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Quantity: 0.300 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Quantity: 0.300 mg in 1 1
Code: 3WJQ0SDW1A
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
trifluridine and tipiracil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64842-1020
Application NumberNDA207981
Product Classification
M
Marketing Category
C73594
G
Generic Name
trifluridine and tipiracil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 8, 2023
FDA Product Classification
INGREDIENTS (12)
TIPIRACIL HYDROCHLORIDEActive
Quantity: 8.19 mg in 1 1
Code: 4H59KLQ0A4
Classification: ACTIM
TRIFLURIDINEActive
Quantity: 20 mg in 1 1
Code: RMW9V5RW38
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Quantity: 120.980 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Quantity: 8.000 mg in 1 1
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Quantity: 2.800 mg in 1 1
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Quantity: 1.600 mg in 1 1
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Quantity: 0.400 mg in 1 1
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Quantity: 0.400 mg in 1 1
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Quantity: 0.040 mg in 1 1
Code: 1K09F3G675
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 0.004 mg in 1 1
Code: 70097M6I30
Classification: IACT