Lenvima

Product NDC: 62856-710
11-digit product format: 628560710
Labeler code: 62856
Product ID: 62856-710_1e331ae1-f681-4783-a4f7-bcac2eab9967
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lenvatinib
Dosage form: CAPSULE
Route: ORAL
Labeler: Eisai Inc.
Application: NDA206947
Marketing category: NDA
Marketing start: 2015-02-13
Substance: LENVATINIB
Active strength: 10 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Receptor Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206947-001	LENVIMA	EQ 4MG BASE	CAPSULE / ORAL	RLD	2015-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206947-002	LENVIMA	EQ 10MG BASE	CAPSULE / ORAL	RLD, RS	2015-02-13	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 884 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206947-001	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	7253286*PED	2026-04-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	7612208*PED	2027-03-19		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	9006256	2027-07-27	U-1695		2015-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	9006256*PED	2028-01-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12508313	2030-10-04		Drug product	2025-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12508313*PED	2031-04-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10259791	2035-08-26		Drug substance	2019-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10407393	2035-08-26		Drug substance	2019-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11186547	2035-08-26		Drug substance	2021-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11090386	2036-02-23	U-3519		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10259791*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	10407393*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11186547*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12083112	2036-03-03	U-3996		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12083112	2036-03-03	U-3997		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	11090386*PED	2036-08-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12083112*PED	2036-09-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12226409	2038-05-15	U-4146		2025-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-001	12226409*PED	2038-11-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7253286	2025-10-24		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7253286*PED	2026-04-24		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7612208	2026-09-19		Drug substance, Drug product	2015-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	7612208*PED	2027-03-19		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	9006256	2027-07-27	U-1695		2015-05-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	9006256*PED	2028-01-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12508313	2030-10-04		Drug product	2025-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12508313*PED	2031-04-04		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10259791	2035-08-26		Drug substance	2019-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10407393	2035-08-26		Drug substance	2019-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11186547	2035-08-26		Drug substance	2021-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11090386	2036-02-23	U-3519		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10259791*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	10407393*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11186547*PED	2036-02-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12083112	2036-03-03	U-3996		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12083112	2036-03-03	U-3997		2024-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	11090386*PED	2036-08-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206947-002	12083112*PED	2036-09-03		Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 12 · 442 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	M-269	2024-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	I-868	2024-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	M-272	2024-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	ODE-196	2025-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	PED	2026-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	M-14	2027-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-001	PED	2027-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	M-269	2024-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	I-868	2024-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	M-272	2024-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	ODE-196	2025-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	PED	2026-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	M-14	2027-04-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206947-002	PED	2027-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	M-269	2024-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	I-868	2024-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	M-272	2024-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	ODE-196	2025-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	PED	2026-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	M-14	2027-04-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-001	PED	2027-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-002	M-269	2024-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-002	I-868	2024-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206947-002	M-272	2024-12-19	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LENVATINIB	10 mg/1

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
62856-710-05	Lenvima	5 in 1 BLISTER PACK	CAPSULE	5		78
62856-710-30	Lenvima	6 in 1 BOX, UNIT-DOSE	CAPSULE	6		78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62856-710-05	EA - Each	62856-710	99cdc777-b9e7-4889-ac6c-f92ac8df0d67	1	2015-03-03
62856-710-30	EA - Each	62856-710	b80bf62f-c409-40ef-ae81-597674bcd4f8	1	2015-03-03

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
62856-710	LENVIMA (LENVATINIB) CAPSULE LENVIMA (LENVATINIB) KIT [EISAI INC.]	77	Current NDC, Legacy NDC, 2 package rows	20250210_f4bedd21-efde-44c6-9d9c-b48b78d7ed1e.zip

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
62856-710-05	62856071005	5 in 1 BLISTER PACK						Historical
62856-710-30	62856071030	6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-710-30) / 5 CAPSULE in 1 BLISTER PACK (62856-710-05)	6 blister pack	2015-02-13	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 \| Sharp Packaging Services, LLC	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	81