Lenvima

Product NDC: 62856-718
11-digit product format: 628560718
Labeler code: 62856
Product ID: 62856-718_980cbc09-76e3-4b8f-a8c4-d8adf6743b55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lenvatinib
Dosage form: KIT
Labeler: Eisai Inc.
Application: NDA206947
Marketing category: NDA
Marketing start: 2016-05-13
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206947-001	LENVIMA	LENVATINIB MESYLATE	EQ 4MG BASE	CAPSULE / ORAL		RLD	2015-02-13
N206947-002	LENVIMA	LENVATINIB MESYLATE	EQ 10MG BASE	CAPSULE / ORAL		RLD, RS	2015-02-13

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10
N206947-001	7253286*PED	2026-04-24		Pediatric extension
N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10
N206947-001	7612208*PED	2027-03-19		Pediatric extension
N206947-001	9006256	2027-07-27	U-1695		2015-05-12
N206947-001	9006256*PED	2028-01-27		Pediatric extension
N206947-001	12508313	2030-10-04		Drug product	2025-12-30
N206947-001	12508313*PED	2031-04-04		Pediatric extension
N206947-001	10259791	2035-08-26		Drug substance	2019-05-13
N206947-001	10407393	2035-08-26		Drug substance	2019-10-04
N206947-001	11186547	2035-08-26		Drug substance	2021-12-17
N206947-001	11090386	2036-02-23	U-3519		2023-02-10
N206947-001	10259791*PED	2036-02-26		Pediatric extension
N206947-001	10407393*PED	2036-02-26		Pediatric extension
N206947-001	11186547*PED	2036-02-26		Pediatric extension
N206947-001	12083112	2036-03-03	U-3996		2024-10-03
N206947-001	12083112	2036-03-03	U-3997		2024-10-03
N206947-001	11090386*PED	2036-08-23		Pediatric extension
N206947-001	12083112*PED	2036-09-03		Pediatric extension
N206947-001	12226409	2038-05-15	U-4146		2025-03-07
N206947-001	12226409*PED	2038-11-15		Pediatric extension
N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10
N206947-002	7253286*PED	2026-04-24		Pediatric extension
N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10
N206947-002	7612208*PED	2027-03-19		Pediatric extension
N206947-002	9006256	2027-07-27	U-1695		2015-05-12
N206947-002	9006256*PED	2028-01-27		Pediatric extension
N206947-002	12508313	2030-10-04		Drug product	2025-12-30
N206947-002	12508313*PED	2031-04-04		Pediatric extension
N206947-002	10259791	2035-08-26		Drug substance	2019-05-13
N206947-002	10407393	2035-08-26		Drug substance	2019-10-04
N206947-002	11186547	2035-08-26		Drug substance	2021-12-17
N206947-002	11090386	2036-02-23	U-3519		2023-02-10
N206947-002	10259791*PED	2036-02-26		Pediatric extension
N206947-002	10407393*PED	2036-02-26		Pediatric extension
N206947-002	11186547*PED	2036-02-26		Pediatric extension
N206947-002	12083112	2036-03-03	U-3996		2024-10-03
N206947-002	12083112	2036-03-03	U-3997		2024-10-03
N206947-002	11090386*PED	2036-08-23		Pediatric extension
N206947-002	12083112*PED	2036-09-03		Pediatric extension
N206947-002	12226409	2038-05-15	U-4146		2025-03-07
N206947-002	12226409*PED	2038-11-15		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N206947-001	ODE-196	2025-08-15
N206947-001	PED	2026-02-15
N206947-001	M-14	2027-04-03
N206947-001	PED	2027-10-03
N206947-002	ODE-196	2025-08-15
N206947-002	PED	2026-02-15
N206947-002	M-14	2027-04-03
N206947-002	PED	2027-10-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 800 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	7253286*PED	2026-04-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	7612208*PED	2027-03-19		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	9006256	2027-07-27	U-1695		2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	9006256*PED	2028-01-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12508313	2030-10-04		Drug product	2025-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12508313*PED	2031-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10259791	2035-08-26		Drug substance	2019-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10407393	2035-08-26		Drug substance	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11186547	2035-08-26		Drug substance	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11090386	2036-02-23	U-3519		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10259791*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	10407393*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11186547*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12083112	2036-03-03	U-3996		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12083112	2036-03-03	U-3997		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	11090386*PED	2036-08-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12083112*PED	2036-09-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12226409	2038-05-15	U-4146		2025-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	12226409*PED	2038-11-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7253286*PED	2026-04-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	7612208*PED	2027-03-19		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	9006256	2027-07-27	U-1695		2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	9006256*PED	2028-01-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12508313	2030-10-04		Drug product	2025-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12508313*PED	2031-04-04		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10259791	2035-08-26		Drug substance	2019-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10407393	2035-08-26		Drug substance	2019-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11186547	2035-08-26		Drug substance	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11090386	2036-02-23	U-3519		2023-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10259791*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	10407393*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11186547*PED	2036-02-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12083112	2036-03-03	U-3996		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12083112	2036-03-03	U-3997		2024-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	11090386*PED	2036-08-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	12083112*PED	2036-09-03		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 426 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206947-001	ODE-196	2025-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	PED	2026-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	M-14	2027-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-001	PED	2027-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	ODE-196	2025-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	PED	2026-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	M-14	2027-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206947-002	PED	2027-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	ODE-196	2025-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	PED	2026-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	M-14	2027-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-001	PED	2027-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	ODE-196	2025-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	PED	2026-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	M-14	2027-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206947-002	PED	2027-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206947-001	ODE-196	2025-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-001	PED	2026-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-001	M-14	2027-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-001	PED	2027-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	ODE-196	2025-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	PED	2026-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	M-14	2027-04-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206947-002	PED	2027-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	ODE-196	2025-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	PED	2026-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	M-14	2027-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-001	PED	2027-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	ODE-196	2025-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	PED	2026-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	M-14	2027-04-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206947-002	PED	2027-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	ODE-196	2025-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	PED	2026-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	M-14	2027-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-001	PED	2027-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	ODE-196	2025-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	PED	2026-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	M-14	2027-04-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206947-002	PED	2027-10-03	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lenvima
Listing expiration: 2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EE083865G2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1604345	Internal RxNorm lookup
1604348	Internal RxNorm lookup
1604349	Internal RxNorm lookup
1604350	Internal RxNorm lookup
1604351	Internal RxNorm lookup
1604352	Internal RxNorm lookup
1604383	Internal RxNorm lookup
1604384	Internal RxNorm lookup
1604394	Internal RxNorm lookup
1604395	Internal RxNorm lookup
1792377	Internal RxNorm lookup
1792392	Internal RxNorm lookup
1792393	Internal RxNorm lookup
1796538	Internal RxNorm lookup
1796664	Internal RxNorm lookup
1796665	Internal RxNorm lookup
2054156	Internal RxNorm lookup
2054157	Internal RxNorm lookup
2054158	Internal RxNorm lookup
2054159	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c465cba-54a9-406c-8a99-04507dce89f2	Product name	2	20181121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62856-718-05	Lenvima	1 in 1 BLISTER PACK	KIT	1		78
62856-718-30	Lenvima	6 in 1 BOX	KIT	6		78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62856-718-05	EA - Each	62856-718	3e91b653-3912-4d16-ab78-45a4ec11429e	1	2016-06-14
62856-718-30	EA - Each	62856-718	fedf1166-41cc-48b6-bcf0-aef299d098d8	1	2016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LENVATINIB	ACTIVE INGREDIENT	EE083865G2	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
LENVATINIB	ACTIVE MOIETY	EE083865G2	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62856-718	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	77	Current NDC, Legacy NDC, 2 package rows	20250210_f4bedd21-efde-44c6-9d9c-b48b78d7ed1e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lenvima	LENVATINIB	Eisai Inc.	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206947 application number: NDA206947 ndc (product): 62856-718

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EE083865G2	LENVATINIB	417716-92-8	Lenvatinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1604384	{30 (lenvatinib 10 MG Oral Capsule [Lenvima]) } Pack [Lenvima 10]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604350	{30 (lenvatinib 10 MG Oral Capsule [Lenvima]) / 30 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 14]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792393	{30 (lenvatinib 10 MG Oral Capsule [Lenvima]) / 60 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 18]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054157	{30 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 4]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604395	{60 (lenvatinib 10 MG Oral Capsule [Lenvima]) } Pack [Lenvima 20]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604352	{60 (lenvatinib 10 MG Oral Capsule [Lenvima]) / 30 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 24]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796665	{60 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 8]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054159	{90 (lenvatinib 4 MG Oral Capsule [Lenvima]) } Pack [Lenvima 12]	BPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604383	{30 (lenvatinib 10 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604349	{30 (lenvatinib 10 MG Oral Capsule) / 30 (lenvatinib 4 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792392	{30 (lenvatinib 10 MG Oral Capsule) / 60 (lenvatinib 4 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054156	{30 (lenvatinib 4 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604394	{60 (lenvatinib 10 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604351	{60 (lenvatinib 10 MG Oral Capsule) / 30 (lenvatinib 4 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796664	{60 (lenvatinib 4 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054158	{90 (lenvatinib 4 MG Oral Capsule) } Pack	GPCK	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604383	lenvatinib 10 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604345	lenvatinib 10 MG Oral Capsule	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054158	lenvatinib 12 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604349	lenvatinib 14 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792392	lenvatinib 18 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604394	lenvatinib 20 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604351	lenvatinib 24 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054156	lenvatinib 4 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604348	lenvatinib 4 MG Oral Capsule	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796664	lenvatinib 8 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604384	Lenvima 10 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796538	Lenvima 10 MG Oral Capsule	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054159	Lenvima 12 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604350	Lenvima 14 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792393	Lenvima 18 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604395	Lenvima 20 MG Daily Dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604352	Lenvima 24 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054157	Lenvima 4 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792377	Lenvima 4 MG Oral Capsule	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796665	Lenvima 8 MG daily dose 30 Day Supply Pack	PSN	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796538	lenvatinib 10 MG Oral Capsule [Lenvima]	SBD	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792377	lenvatinib 4 MG Oral Capsule [Lenvima]	SBD	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604345	lenvatinib 10 MG Oral Capsule	SCD	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604348	lenvatinib 4 MG Oral Capsule	SCD	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604345	lenvatinib 10 MG (as lenvatinib mesylate 12.25 MG) Oral Capsule	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604383	lenvatinib 10 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054158	lenvatinib 12 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054158	lenvatinib 12 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792392	lenvatinib 14 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604349	lenvatinib 14 MG (as mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604349	lenvatinib 14 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604394	lenvatinib 20 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604394	lenvatinib 20 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604351	lenvatinib 24 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604351	lenvatinib 24 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604348	lenvatinib 4 MG (as lenvatinib mesylate 4.9 MG) Oral Capsule	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054156	lenvatinib 4 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796664	lenvatinib 8 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796664	lenvatinib 8 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604384	Lenvima 10 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604384	Lenvima 10 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796538	Lenvima 10 MG Oral Capsule	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054159	Lenvima 12 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604350	Lenvima 14 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604350	Lenvima 14 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792393	Lenvima 18 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604395	Lenvima 20 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604395	Lenvima 20 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604352	Lenvima 24 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1604352	Lenvima 24 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
2054157	Lenvima 4 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1792377	Lenvima 4 MG Oral Capsule	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796665	Lenvima 8 MG (as lenvatinib mesylate) Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78
1796665	Lenvima 8 MG Daily Dose 30 Day Supply Pack	SY	f4bedd21-efde-44c6-9d9c-b48b78d7ed1e	78

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62856-718-05	62856071805	1 in 1 BLISTER PACK						Historical
62856-718-30	62856071830	6 BLISTER PACK in 1 BOX (62856-718-30) / 1 KIT in 1 BLISTER PACK (62856-718-05)	6 blister pack	2016-05-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lenvima	Eisai Inc. \| Eisai Co., Ltd. \| Pace Analytical Life Sciences, LLC \| Patheon Inc. \| Pharma Packaging Solutions, LLC dba Tjoapack, LLC \| Sharp Packaging Services, LLC	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	80