Lenvima
These highlights do not include all the information needed to use LENVIMA safely and effectively. See full prescribing information for LENVIMA . LENVIMA ( lenvatinib ) capsules , for oral use Initial U.S. Approval: 2015
Approved
Approval ID
f4bedd21-efde-44c6-9d9c-b48b78d7ed1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Eisai Inc.
DUNS: 189246791
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-712
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (15)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LENVATINIBActive
Quantity: 4 mg in 1 1
Code: EE083865G2
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-720
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (15)
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
LENVATINIBActive
Quantity: 10 mg in 1 1
Code: EE083865G2
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-708
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (15)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
LENVATINIBActive
Quantity: 4 mg in 1 1
Code: EE083865G2
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-704
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (15)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
LENVATINIBActive
Quantity: 4 mg in 1 1
Code: EE083865G2
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-718
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Effective DateOctober 26, 2023
FDA Product Classification
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-724
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Effective DateOctober 26, 2023
FDA Product Classification
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-714
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Effective DateOctober 26, 2023
FDA Product Classification
Lenvatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-710
Application NumberNDA206947
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lenvatinib
Product Specifications
Route of AdministrationORAL
Effective DateOctober 26, 2023
FDA Product Classification
INGREDIENTS (15)
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LENVATINIBActive
Quantity: 10 mg in 1 1
Code: EE083865G2
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT