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

NDC Product Code62856-712

Application NumberNDA206947

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 26, 2023

Generic NameLenvatinib

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

NDC Product Code62856-720

Application NumberNDA206947

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 26, 2023

Generic NameLenvatinib

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

NDC Product Code62856-708

Application NumberNDA206947

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 26, 2023

Generic NameLenvatinib

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

NDC Product Code62856-704

Application NumberNDA206947

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 26, 2023

Generic NameLenvatinib

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

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

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Lenvima

Products 8

Lenvatinib

PRODUCT DETAILS

INGREDIENTS (15)

Lenvatinib

PRODUCT DETAILS

INGREDIENTS (15)

Lenvatinib

PRODUCT DETAILS

INGREDIENTS (15)

Lenvatinib

PRODUCT DETAILS

INGREDIENTS (15)

Lenvatinib

PRODUCT DETAILS

Lenvatinib

PRODUCT DETAILS

Lenvatinib

PRODUCT DETAILS

Lenvatinib

PRODUCT DETAILS

INGREDIENTS (15)

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