INGREZZA

Product NDC: 70370-2048
11-digit product format: 703702048
Labeler code: 70370
Product ID: 70370-2048_bbfcd3d3-5b8b-411d-9cb6-3521a4e36e6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valbenazine
Dosage form: KIT
Route: ORAL
Labeler: Neurocrine Biosciences, Inc.
Application: NDA209241
Marketing category: NDA
Marketing start: 2018-12-14
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209241-001	INGREZZA	VALBENAZINE TOSYLATE	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11
N209241-002	INGREZZA	VALBENAZINE TOSYLATE	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04
N209241-003	INGREZZA	VALBENAZINE TOSYLATE	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N209241-001	AB
N209241-002	AB

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
N209241-001	8357697	2027-11-08	U-1995		2017-04-26
N209241-001	8357697	2027-11-08	U-3055		2017-04-26
N209241-001	8039627	2031-04-11		Drug substance, Drug product	2017-04-26
N209241-001	10065952	2036-10-28	U-1995	Drug substance, Drug product	2018-09-26
N209241-001	10065952	2036-10-28	U-3055	Drug substance, Drug product	2018-09-26
N209241-001	10844058	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18
N209241-001	10844058	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18
N209241-001	10851103	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18
N209241-001	10851103	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18
N209241-001	10851104	2036-10-28	U-1995	Drug substance	2020-12-18
N209241-001	10851104	2036-10-28	U-3055	Drug substance	2020-12-18
N209241-001	10906902	2036-12-22		Drug substance, Drug product	2021-03-03
N209241-001	10906903	2036-12-22		Drug substance, Drug product	2021-03-03
N209241-001	10919892	2036-12-22		Drug substance, Drug product	2021-03-03
N209241-001	10857137	2037-10-10	U-1995		2020-12-18
N209241-001	10857148	2037-10-10	U-1995		2020-12-18
N209241-001	10874648	2037-10-10	U-1995		2021-01-25
N209241-001	10874648	2037-10-10	U-3046		2021-01-25
N209241-001	10874648	2037-10-10	U-3055		2021-01-25
N209241-001	10912771	2037-10-10	U-1995		2021-03-03
N209241-001	10912771	2037-10-10	U-3055		2021-03-03
N209241-001	10912771	2037-10-10	U-3076		2021-03-03
N209241-001	10952997	2037-10-10	U-1995		2021-04-06
N209241-001	10993941	2037-10-10	U-1995		2021-05-19
N209241-001	11040029	2037-10-10	U-1995		2021-06-30
N209241-001	11439629	2037-10-10	U-3055		2023-09-14
N209241-001	11026939	2038-09-18	U-1995	Drug product	2021-06-30
N209241-001	11026939	2038-09-18	U-3055	Drug product	2021-06-30
N209241-001	11311532	2038-09-18	U-1995	Drug product	2022-05-17
N209241-001	11311532	2038-09-18	U-3055	Drug product	2022-05-17
N209241-001	11654142	2038-11-14	U-3055		2023-09-14
N209241-001	11026931	2039-08-14	U-1995		2021-06-30
N209241-001	10940141	2040-08-10	U-1995		2021-04-06
N209241-002	8357697	2027-11-08	U-1995		2017-10-27
N209241-002	8357697	2027-11-08	U-3055		2017-10-27
N209241-002	8039627	2031-04-11		Drug substance, Drug product	2017-10-27
N209241-002	10065952	2036-10-28	U-1995	Drug substance, Drug product	2018-09-26
N209241-002	10065952	2036-10-28	U-3055	Drug substance, Drug product	2018-09-26
N209241-002	10844058	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18
N209241-002	10844058	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18
N209241-002	10851103	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18
N209241-002	10851103	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18
N209241-002	10851104	2036-10-28	U-1995	Drug substance	2020-12-18
N209241-002	10851104	2036-10-28	U-3055	Drug substance	2020-12-18
N209241-002	10906902	2036-12-22		Drug substance, Drug product	2021-03-03
N209241-002	10906903	2036-12-22		Drug substance, Drug product	2021-03-03
N209241-002	10919892	2036-12-22		Drug substance, Drug product	2021-03-03
N209241-002	10857137	2037-10-10	U-1995		2020-12-18
N209241-002	10857148	2037-10-10	U-1995		2020-12-18
N209241-002	10874648	2037-10-10	U-1995		2021-01-25
N209241-002	10874648	2037-10-10	U-3046		2021-01-25
N209241-002	10874648	2037-10-10	U-3055		2021-01-25
N209241-002	10912771	2037-10-10	U-1995		2021-03-03
N209241-002	10912771	2037-10-10	U-3055		2021-03-03
N209241-002	10912771	2037-10-10	U-3076		2021-03-03
N209241-002	10952997	2037-10-10	U-1995		2021-04-06
N209241-002	10993941	2037-10-10	U-1995		2021-05-19
N209241-002	11040029	2037-10-10	U-1995		2021-06-30
N209241-002	11439629	2037-10-10	U-3055		2023-09-14
N209241-002	11026939	2038-09-18	U-1995	Drug product	2021-06-30
N209241-002	11026939	2038-09-18	U-3055	Drug product	2021-06-30
N209241-002	11311532	2038-09-18	U-1995	Drug product	2022-05-17
N209241-002	11311532	2038-09-18	U-3055	Drug product	2022-05-17
N209241-002	11654142	2038-11-14	U-3055		2023-09-14
N209241-002	11026931	2039-08-14	U-1995		2021-06-30
N209241-002	10940141	2040-08-10	U-1995		2021-04-06
N209241-003	8357697	2027-11-08	U-1995		2021-05-19
N209241-003	8357697	2027-11-08	U-3055		2021-05-19
N209241-003	8039627	2031-04-11		Drug substance, Drug product	2021-05-19
N209241-003	10065952	2036-10-28	U-1995	Drug substance, Drug product	2021-05-19
N209241-003	10065952	2036-10-28	U-3055	Drug substance, Drug product	2021-05-19
N209241-003	10844058	2036-10-28	U-1995	Drug substance, Drug product	2021-05-19
N209241-003	10844058	2036-10-28	U-3055	Drug substance, Drug product	2021-05-19
N209241-003	10851103	2036-10-28	U-1995	Drug substance, Drug product	2021-05-19
N209241-003	10851103	2036-10-28	U-3055	Drug substance, Drug product	2021-05-19
N209241-003	10851104	2036-10-28	U-1995	Drug substance	2021-05-19
N209241-003	10851104	2036-10-28	U-3055	Drug substance	2021-05-19
N209241-003	10906902	2036-12-22		Drug substance, Drug product	2021-05-19
N209241-003	10906903	2036-12-22		Drug substance, Drug product	2021-05-19
N209241-003	10919892	2036-12-22		Drug substance, Drug product	2021-05-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209241-001	I-925	2026-08-18
N209241-001	ODE-440	2030-08-18
N209241-002	I-925	2026-08-18
N209241-002	ODE-440	2030-08-18
N209241-003	I-925	2026-08-18
N209241-003	ODE-440	2030-08-18

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 4 · 121 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL		RLD	2021-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209241-002	INGREZZA	EQ 80MG BASE	CAPSULE / ORAL	AB	RLD, RS	2017-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209241-003	INGREZZA	EQ 60MG BASE	CAPSULE / ORAL	AB	RLD	2021-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209241-001	INGREZZA	EQ 40MG BASE	CAPSULE / ORAL	AB	RLD	2017-04-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N209241-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209241-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209241-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209241-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209241-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209241-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209241-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209241-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209241-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209241-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209241-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209241-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209241-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209241-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209241-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209241-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209241-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209241-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209241-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209241-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209241-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209241-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209241-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209241-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209241-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209241-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209241-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209241-002	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209241-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 78 · 3,114 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	N209241-001	8357697	2027-11-08	U-3055		2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	8357697	2027-11-08	U-1995		2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	8039627	2031-04-11		Drug substance, Drug product	2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10065952	2036-10-28	U-1995	Drug substance, Drug product	2018-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10065952	2036-10-28	U-3055	Drug substance, Drug product	2018-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10844058	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10844058	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10851103	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10851103	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10851104	2036-10-28	U-1995	Drug substance	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10851104	2036-10-28	U-3055	Drug substance	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10906902	2036-12-22		Drug substance, Drug product	2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10906903	2036-12-22		Drug substance, Drug product	2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10919892	2036-12-22		Drug substance, Drug product	2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10857137	2037-10-10	U-1995		2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10857148	2037-10-10	U-1995		2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10874648	2037-10-10	U-1995		2021-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10874648	2037-10-10	U-3046		2021-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10874648	2037-10-10	U-3055		2021-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10912771	2037-10-10	U-3055		2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10912771	2037-10-10	U-1995		2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10912771	2037-10-10	U-3076		2021-03-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10952997	2037-10-10	U-1995		2021-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10993941	2037-10-10	U-1995		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11040029	2037-10-10	U-1995		2021-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11439629	2037-10-10	U-3055		2023-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11026939	2038-09-18	U-3055	Drug product	2021-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11026939	2038-09-18	U-1995	Drug product	2021-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11311532	2038-09-18	U-1995	Drug product	2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11311532	2038-09-18	U-3055	Drug product	2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11654142	2038-11-14	U-3055		2023-09-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	11026931	2039-08-14	U-1995		2021-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	10940141	2040-08-10	U-1995		2021-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	8357697	2027-11-08	U-1995		2017-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	8357697	2027-11-08	U-3055		2017-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	8039627	2031-04-11		Drug substance, Drug product	2017-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	10065952	2036-10-28	U-1995	Drug substance, Drug product	2018-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	10065952	2036-10-28	U-3055	Drug substance, Drug product	2018-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	10844058	2036-10-28	U-1995	Drug substance, Drug product	2020-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	10844058	2036-10-28	U-3055	Drug substance, Drug product	2020-12-18	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 172 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	N209241-001	I-925	2026-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-001	ODE-440	2030-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	I-925	2026-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-002	ODE-440	2030-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-003	I-925	2026-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209241-003	ODE-440	2030-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209241-001	I-925	2026-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-001	ODE-440	2030-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-002	I-925	2026-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-002	ODE-440	2030-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-003	I-925	2026-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209241-003	ODE-440	2030-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209241-001	I-925	2026-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-001	ODE-440	2030-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-002	I-925	2026-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-002	ODE-440	2030-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-003	I-925	2026-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209241-003	ODE-440	2030-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-001	I-925	2026-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-001	ODE-440	2030-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-002	I-925	2026-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-002	ODE-440	2030-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-003	I-925	2026-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209241-003	ODE-440	2030-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209241-001	I-925	2026-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-001	ODE-440	2030-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-002	I-925	2026-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-002	ODE-440	2030-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-003	I-925	2026-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209241-003	ODE-440	2030-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-001	I-925	2026-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-001	ODE-440	2030-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-002	I-925	2026-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-002	ODE-440	2030-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-003	I-925	2026-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209241-003	ODE-440	2030-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-001	I-925	2026-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-001	ODE-440	2030-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-002	I-925	2026-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209241-002	ODE-440	2030-08-18	`b8a1b40f171c…`

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: INGREZZA
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
5SML1T733B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1918224	Internal RxNorm lookup
1918230	Internal RxNorm lookup
1986329	Internal RxNorm lookup
1986331	Internal RxNorm lookup
2054268	Internal RxNorm lookup
2054269	Internal RxNorm lookup
2541511	Internal RxNorm lookup
2541513	Internal RxNorm lookup
2665627	Internal RxNorm lookup
2665628	Internal RxNorm lookup
2680779	Internal RxNorm lookup
2680780	Internal RxNorm lookup
2680781	Internal RxNorm lookup
2680782	Internal RxNorm lookup
2680783	Internal RxNorm lookup
2680784	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
4c970164-cafb-421f-9eb5-c226ef0a3417	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d2cb1284-41f6-4b6d-890e-9e251669f976	Product name	3	20250129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70370-2048-6	INGREZZA	1 in 1 BLISTER PACK	KIT	1		34
70370-2048-6	INGREZZA	1 in 1 CARTON	KIT	1		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70370-2048-6	EA - Each	70370-2048	14e209b7-f192-4b9e-ba29-3618a720b8ea	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70370-2048	INGREZZA (VALBENAZINE) CAPSULE INGREZZA (VALBENAZINE) KIT INGREZZA SPRINKLE (VALBENAZINE) CAPSULE [NEUROCRINE BIOSCIENCES, INC.]	32	Current NDC, Legacy NDC, 2 package rows	20250221_4c970164-cafb-421f-9eb5-c226ef0a3417.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
INGREZZA	VALBENAZINE	Neurocrine Biosciences, Inc.	4c970164-cafb-421f-9eb5-c226ef0a3417	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209241 application number: NDA209241 ndc (product): 70370-2048

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
54K37P50KH	VALBENAZINE	1025504-45-3	Valbenazine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2665628	{14 (valbenazine 40 MG Oral Capsule [Ingrezza]) / 14 (valbenazine 60 MG Oral Capsule [Ingrezza]) } Pack [Ingrezza 40/60 Initiation Pack]	BPCK	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2054269	{7 (valbenazine 40 MG Oral Capsule [Ingrezza]) / 21 (valbenazine 80 MG Oral Capsule [Ingrezza]) } Pack [Ingrezza]	BPCK	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2665627	{14 (valbenazine 40 MG Oral Capsule) / 14 (valbenazine 60 MG Oral Capsule) } Pack	GPCK	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2054268	{7 (valbenazine 40 MG Oral Capsule) / 21 (valbenazine 80 MG Oral Capsule) } Pack	GPCK	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2665628	INGREZZA 40 MG / 60 MG Initiation Pack	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2054269	INGREZZA 40 MG / 80 MG Starter Pack	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918230	INGREZZA 40 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2541513	INGREZZA 60 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1986331	INGREZZA 80 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680780	INGREZZA SPRINKLE 40 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680782	INGREZZA SPRINKLE 60 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680784	INGREZZA SPRINKLE 80 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2665627	valbenazine 40 MG / 60 MG Initiation Pack	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2054268	valbenazine 40 MG / 80 MG Starter Pack	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918224	valbenazine 40 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680779	valbenazine 40 MG Sprinkle Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2541511	valbenazine 60 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680781	valbenazine 60 MG Sprinkle Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1986329	valbenazine 80 MG Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680783	valbenazine 80 MG Sprinkle Oral Capsule	PSN	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680780	Sprinkle valbenazine 40 MG Oral Capsule [Ingrezza]	SBD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680782	Sprinkle valbenazine 60 MG Oral Capsule [Ingrezza]	SBD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680784	Sprinkle valbenazine 80 MG Oral Capsule [Ingrezza]	SBD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918230	valbenazine 40 MG Oral Capsule [Ingrezza]	SBD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2541513	valbenazine 60 MG Oral Capsule [Ingrezza]	SBD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1986331	valbenazine 80 MG Oral Capsule [Ingrezza]	SBD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680779	Sprinkle valbenazine 40 MG Oral Capsule	SCD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680781	Sprinkle valbenazine 60 MG Oral Capsule	SCD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680783	Sprinkle valbenazine 80 MG Oral Capsule	SCD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918224	valbenazine 40 MG Oral Capsule	SCD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2541511	valbenazine 60 MG Oral Capsule	SCD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1986329	valbenazine 80 MG Oral Capsule	SCD	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918230	Ingrezza 40 MG (as valbenazine tosylate 73 MG) Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2665628	INGREZZA 40 MG / 60 MG Initiation Pack, 28 capsules	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2054269	INGREZZA 40 MG / 80 MG Starter Pack, 28 capsules	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918230	Ingrezza 40 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2541513	Ingrezza 60 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1986331	Ingrezza 80 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680780	Ingrezza Sprinkle 40 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680782	Ingrezza Sprinkle 60 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680784	Ingrezza Sprinkle 80 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680779	valbenazine (as valbenazine tosylate) 40 MG Sprinkle Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2541511	valbenazine (as valbenazine tosylate) 60 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680781	valbenazine (as valbenazine tosylate) 60 MG Sprinkle Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1986329	valbenazine (as valbenazine tosylate) 80 MG Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2680783	valbenazine (as valbenazine tosylate) 80 MG Sprinkle Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
1918224	valbenazine 40 MG (as valbenazine tosylate 73 MG) Oral Capsule	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2665627	valbenazine 40 MG / 60 MG Initiation Pack, 28 capsules	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34
2054268	valbenazine 40 MG / 80 MG Starter Pack, 28 capsules	SY	4c970164-cafb-421f-9eb5-c226ef0a3417	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70370-2048-6	70370204806	1 BLISTER PACK in 1 CARTON (70370-2048-6) / 1 KIT in 1 BLISTER PACK	1 blister pack	2018-12-14	0000-00-00	No	No	Current