Application 218390

Type: NDA
Sponsor: NEUROCRINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	CAPSULE;ORAL	EQ 40MG BASE	Yes	No
002	INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	CAPSULE;ORAL	EQ 60MG BASE	Yes	No
003	INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	CAPSULE;ORAL	EQ 80MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N218390-001	INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30
N218390-002	INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30
N218390-003	INGREZZA SPRINKLE	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30

Orange Book patents#

Current patent rows page 1 of 2 · 99 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218390-001	8357697	2027-11-08	U-1995		2024-05-13
N218390-001	8357697	2027-11-08	U-3055		2024-05-13
N218390-001	8039627	2031-04-11		Drug substance, Drug product	2024-05-13
N218390-001	10065952	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-001	10065952	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-001	10844058	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-001	10844058	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-001	10851103	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-001	10851103	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-001	10851104	2036-10-28	U-1995	Drug substance	2024-05-13
N218390-001	10851104	2036-10-28	U-3055	Drug substance	2024-05-13
N218390-001	10906902	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-001	10906903	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-001	10919892	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-001	10857137	2037-10-10	U-1995		2024-05-13
N218390-001	10857148	2037-10-10	U-1995		2024-05-13
N218390-001	10874648	2037-10-10	U-1995		2024-05-13
N218390-001	10874648	2037-10-10	U-3046		2024-05-13
N218390-001	10874648	2037-10-10	U-3055		2024-05-13
N218390-001	10912771	2037-10-10	U-1995		2024-05-13
N218390-001	10912771	2037-10-10	U-3055		2024-05-13
N218390-001	10912771	2037-10-10	U-3076		2024-05-13
N218390-001	10952997	2037-10-10	U-1995		2024-05-13
N218390-001	10993941	2037-10-10	U-1995		2024-05-13
N218390-001	11040029	2037-10-10	U-1995		2024-05-13
N218390-001	11439629	2037-10-10	U-3055		2024-05-13
N218390-001	11026939	2038-09-18	U-1995	Drug product	2024-05-13
N218390-001	11026939	2038-09-18	U-3055	Drug product	2024-05-13
N218390-001	11311532	2038-09-18	U-1995	Drug product	2024-05-13
N218390-001	11311532	2038-09-18	U-3055	Drug product	2024-05-13
N218390-001	11654142	2038-11-14	U-3055		2024-05-13
N218390-001	11026931	2039-08-14	U-1995		2024-05-13
N218390-001	10940141	2040-08-10	U-1995		2024-05-13
N218390-002	8357697	2027-11-08	U-1995		2024-05-13
N218390-002	8357697	2027-11-08	U-3055		2024-05-13
N218390-002	8039627	2031-04-11		Drug substance, Drug product	2024-05-13
N218390-002	10065952	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-002	10065952	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-002	10844058	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-002	10844058	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-002	10851103	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-002	10851103	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-002	10851104	2036-10-28	U-1995	Drug substance	2024-05-13
N218390-002	10851104	2036-10-28	U-3055	Drug substance	2024-05-13
N218390-002	10906902	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-002	10906903	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-002	10919892	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-002	10857137	2037-10-10	U-1995		2024-05-13
N218390-002	10857148	2037-10-10	U-1995		2024-05-13
N218390-002	10874648	2037-10-10	U-1995		2024-05-13
N218390-002	10874648	2037-10-10	U-3046		2024-05-13
N218390-002	10874648	2037-10-10	U-3055		2024-05-13
N218390-002	10912771	2037-10-10	U-1995		2024-05-13
N218390-002	10912771	2037-10-10	U-3055		2024-05-13
N218390-002	10912771	2037-10-10	U-3076		2024-05-13
N218390-002	10952997	2037-10-10	U-1995		2024-05-13
N218390-002	10993941	2037-10-10	U-1995		2024-05-13
N218390-002	11040029	2037-10-10	U-1995		2024-05-13
N218390-002	11439629	2037-10-10	U-3055		2024-05-13
N218390-002	11026939	2038-09-18	U-1995	Drug product	2024-05-13
N218390-002	11026939	2038-09-18	U-3055	Drug product	2024-05-13
N218390-002	11311532	2038-09-18	U-1995	Drug product	2024-05-13
N218390-002	11311532	2038-09-18	U-3055	Drug product	2024-05-13
N218390-002	11654142	2038-11-14	U-3055		2024-05-13
N218390-002	11026931	2039-08-14	U-1995		2024-05-13
N218390-002	10940141	2040-08-10	U-1995		2024-05-13
N218390-003	8357697	2027-11-08	U-1995		2024-05-13
N218390-003	8357697	2027-11-08	U-3055		2024-05-13
N218390-003	8039627	2031-04-11		Drug substance, Drug product	2024-05-13
N218390-003	10065952	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-003	10065952	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-003	10844058	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-003	10844058	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-003	10851103	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13
N218390-003	10851103	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13
N218390-003	10851104	2036-10-28	U-1995	Drug substance	2024-05-13
N218390-003	10851104	2036-10-28	U-3055	Drug substance	2024-05-13
N218390-003	10906902	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-003	10906903	2036-12-22		Drug substance, Drug product	2024-05-13
N218390-003	10919892	2036-12-22		Drug substance, Drug product	2024-05-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218390-001	I-925	2026-08-18
N218390-002	I-925	2026-08-18
N218390-003	I-925	2026-08-18

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 2 · 51 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	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218390-002	INGREZZA SPRINKLE	EQ 60MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218390-003	INGREZZA SPRINKLE	EQ 80MG BASE	CAPSULE / ORAL	RLD, RS	2024-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218390-001	INGREZZA SPRINKLE	EQ 40MG BASE	CAPSULE / ORAL	RLD	2024-04-30	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 40 · 1,584 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	N218390-001	8357697	2027-11-08	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	8357697	2027-11-08	U-3055		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	8039627	2031-04-11		Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10065952	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10065952	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10844058	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10844058	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10851103	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10851103	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10851104	2036-10-28	U-1995	Drug substance	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10851104	2036-10-28	U-3055	Drug substance	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10906902	2036-12-22		Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10906903	2036-12-22		Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10919892	2036-12-22		Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10857137	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10857148	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10874648	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10874648	2037-10-10	U-3055		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10874648	2037-10-10	U-3046		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10912771	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10912771	2037-10-10	U-3076		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10912771	2037-10-10	U-3055		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10952997	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10993941	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11040029	2037-10-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11439629	2037-10-10	U-3055		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11026939	2038-09-18	U-1995	Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11026939	2038-09-18	U-3055	Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11311532	2038-09-18	U-1995	Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11311532	2038-09-18	U-3055	Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11654142	2038-11-14	U-3055		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	11026931	2039-08-14	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-001	10940141	2040-08-10	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	8357697	2027-11-08	U-3055		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	8357697	2027-11-08	U-1995		2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	8039627	2031-04-11		Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	10065952	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	10065952	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	10844058	2036-10-28	U-3055	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	10844058	2036-10-28	U-1995	Drug substance, Drug product	2024-05-13	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218390-001	I-925	2026-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-002	I-925	2026-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218390-003	I-925	2026-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218390-001	I-925	2026-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218390-002	I-925	2026-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218390-003	I-925	2026-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218390-001	I-925	2026-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218390-002	I-925	2026-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218390-003	I-925	2026-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218390-001	I-925	2026-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218390-002	I-925	2026-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218390-003	I-925	2026-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218390-001	I-925	2026-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218390-002	I-925	2026-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218390-003	I-925	2026-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218390-001	I-925	2026-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218390-002	I-925	2026-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218390-003	I-925	2026-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218390-001	I-925	2026-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218390-002	I-925	2026-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218390-003	I-925	2026-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218390-001	I-925	2026-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218390-002	I-925	2026-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218390-003	I-925	2026-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218390-001	I-925	2026-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218390-002	I-925	2026-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218390-003	I-925	2026-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218390-001	I-925	2026-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218390-002	I-925	2026-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218390-003	I-925	2026-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218390-001	I-925	2026-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218390-002	I-925	2026-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218390-003	I-925	2026-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218390-001	I-925	2026-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218390-002	I-925	2026-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218390-003	I-925	2026-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218390-001	I-925	2026-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218390-002	I-925	2026-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218390-003	I-925	2026-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218390-001	I-925	2026-08-18	`301d65b070ca…`

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
INGREZZA	VALBENAZINE	Neurocrine Biosciences, Inc.	4c970164-cafb-421f-9eb5-c226ef0a3417	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218390 application number: NDA218390

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85661	SUPPL	2026-04-09
82127	ORIG	2025-05-01
78329	ORIG	2024-07-23
78343	ORIG	2024-05-02
78330	ORIG	2024-05-01