FDA.reportPublic FDA data

Lenvima

Product NDC
62856-712
11-digit product format
628560712
Labeler code
62856
Product ID
62856-712_980cbc09-76e3-4b8f-a8c4-d8adf6743b55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenvatinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Eisai Inc.
Application
NDA206947
Marketing category
NDA
Marketing start
2018-08-15
Substance
LENVATINIB
Active strength
4 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lenvima
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENVATINIB4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEE083865G2
Rxcui1604345, 1604348, 1604349, 1604350, 1604351, 1604352, 1604383, 1604384, 1604394, 1604395, 1792377, 1792392, 1792393, 1796538, 1796664, 1796665, 2054156, 2054157, 2054158, 2054159

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c465cba-54a9-406c-8a99-04507dce89f2Product name220181121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62856-712-05Lenvima15 in 1 BLISTER PACKCAPSULE1578
62856-712-30Lenvima6 in 1 BOX, UNIT-DOSECAPSULE678

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62856-712-05EA - Each62856-712af361915-a815-408e-b929-3a92f448983512018-09-05
62856-712-30EA - Each62856-712c6f9e429-8cd1-451b-b8b8-bdbc263f9a7b12018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LENVATINIBACTIVE INGREDIENTEE083865G2LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
LENVATINIBACTIVE MOIETYEE083865G2LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ALENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62856-712LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]77Current NDC, Legacy NDC, 2 package rows20250210_f4bedd21-efde-44c6-9d9c-b48b78d7ed1e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1604384{30 (lenvatinib 10 MG Oral Capsule [Lenvima]) } Pack [Lenvima 10]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604350{30 (lenvatinib 10 MG Oral Capsule [Lenvima]) / 30 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 14]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792393{30 (lenvatinib 10 MG Oral Capsule [Lenvima]) / 60 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 18]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054157{30 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 4]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604395{60 (lenvatinib 10 MG Oral Capsule [Lenvima]) } Pack [Lenvima 20]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604352{60 (lenvatinib 10 MG Oral Capsule [Lenvima]) / 30 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 24]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796665{60 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 8]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054159{90 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 12]BPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604383{30 (lenvatinib 10 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604349{30 (lenvatinib 10 MG Oral Capsule) / 30 (lenvatinib 4 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792392{30 (lenvatinib 10 MG Oral Capsule) / 60 (lenvatinib 4 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054156{30 (lenvatinib 4 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604394{60 (lenvatinib 10 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604351{60 (lenvatinib 10 MG Oral Capsule) / 30 (lenvatinib 4 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796664{60 (lenvatinib 4 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054158{90 (lenvatinib 4 MG Oral Capsule) } PackGPCKf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604383lenvatinib 10 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604345lenvatinib 10 MG Oral CapsulePSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054158lenvatinib 12 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604349lenvatinib 14 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792392lenvatinib 18 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604394lenvatinib 20 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604351lenvatinib 24 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054156lenvatinib 4 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604348lenvatinib 4 MG Oral CapsulePSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796664lenvatinib 8 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604384Lenvima 10 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796538Lenvima 10 MG Oral CapsulePSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054159Lenvima 12 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604350Lenvima 14 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792393Lenvima 18 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604395Lenvima 20 MG Daily Dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604352Lenvima 24 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054157Lenvima 4 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792377Lenvima 4 MG Oral CapsulePSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796665Lenvima 8 MG daily dose 30 Day Supply PackPSNf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796538lenvatinib 10 MG Oral Capsule [Lenvima]SBDf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792377lenvatinib 4 MG Oral Capsule [Lenvima]SBDf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604345lenvatinib 10 MG Oral CapsuleSCDf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604348lenvatinib 4 MG Oral CapsuleSCDf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604345lenvatinib 10 MG (as lenvatinib mesylate 12.25 MG) Oral CapsuleSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604383lenvatinib 10 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054158lenvatinib 12 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054158lenvatinib 12 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792392lenvatinib 14 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604349lenvatinib 14 MG (as mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604349lenvatinib 14 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604394lenvatinib 20 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604394lenvatinib 20 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604351lenvatinib 24 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604351lenvatinib 24 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604348lenvatinib 4 MG (as lenvatinib mesylate 4.9 MG) Oral CapsuleSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054156lenvatinib 4 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796664lenvatinib 8 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796664lenvatinib 8 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604384Lenvima 10 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604384Lenvima 10 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796538Lenvima 10 MG Oral CapsuleSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054159Lenvima 12 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604350Lenvima 14 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604350Lenvima 14 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792393Lenvima 18 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604395Lenvima 20 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604395Lenvima 20 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604352Lenvima 24 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1604352Lenvima 24 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
2054157Lenvima 4 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1792377Lenvima 4 MG Oral CapsuleSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796665Lenvima 8 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78
1796665Lenvima 8 MG Daily Dose 30 Day Supply PackSYf4bedd21-efde-44c6-9d9c-b48b78d7ed1e78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62856-712-056285607120515 in 1 BLISTER PACKHistorical
62856-712-30628560712306 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-712-30) / 15 CAPSULE in 1 BLISTER PACK (62856-712-05) 6 blister pack2018-08-150000-00-00NoNoCurrent