Application 205422

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REXULTI	BREXPIPRAZOLE	TABLET;ORAL	0.25MG	Yes	No
002	REXULTI	BREXPIPRAZOLE	TABLET;ORAL	0.5MG	Yes	No
003	REXULTI	BREXPIPRAZOLE	TABLET;ORAL	1MG	Yes	No
004	REXULTI	BREXPIPRAZOLE	TABLET;ORAL	2MG	Yes	Yes
005	REXULTI	BREXPIPRAZOLE	TABLET;ORAL	3MG	Yes	No
006	REXULTI	BREXPIPRAZOLE	TABLET;ORAL	4MG	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205422-001	REXULTI	BREXPIPRAZOLE	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10
N205422-002	REXULTI	BREXPIPRAZOLE	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10
N205422-003	REXULTI	BREXPIPRAZOLE	1MG	TABLET / ORAL	AB	RLD	2015-07-10
N205422-004	REXULTI	BREXPIPRAZOLE	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10
N205422-005	REXULTI	BREXPIPRAZOLE	3MG	TABLET / ORAL	AB	RLD	2015-07-10
N205422-006	REXULTI	BREXPIPRAZOLE	4MG	TABLET / ORAL	AB	RLD	2015-07-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N205422-001	AB
N205422-002	AB
N205422-003	AB
N205422-004	AB
N205422-005	AB
N205422-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 76 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205422-001	8349840	2026-04-12	U-1529	Drug product	2015-07-17
N205422-001	8618109	2026-04-12	U-3281		2015-07-17
N205422-001	8618109	2026-04-12	U-543		2015-07-17
N205422-001	9839637	2026-04-12	U-1529	Drug product	2018-01-09
N205422-001	9839637	2026-04-12	U-3281	Drug product	2018-01-09
N205422-001	9839637	2026-04-12	U-543	Drug product	2018-01-09
N205422-001	8349840*PED	2026-10-12		Pediatric extension
N205422-001	8618109*PED	2026-10-12		Pediatric extension
N205422-001	9839637*PED	2026-10-12		Pediatric extension
N205422-001	RE48059	2028-12-23		Drug substance	2020-07-20
N205422-001	RE48059*PED	2029-06-23		Pediatric extension
N205422-001	10307419	2032-10-12		Drug product	2019-06-14
N205422-001	10307419*PED	2033-04-12		Pediatric extension
N205422-002	8349840	2026-04-12	U-1529	Drug product	2015-07-17
N205422-002	8618109	2026-04-12	U-3281		2015-07-17
N205422-002	8618109	2026-04-12	U-543		2015-07-17
N205422-002	9839637	2026-04-12	U-1529	Drug product	2018-01-09
N205422-002	9839637	2026-04-12	U-3281	Drug product	2018-01-09
N205422-002	9839637	2026-04-12	U-543	Drug product	2018-01-09
N205422-002	8349840*PED	2026-10-12		Pediatric extension
N205422-002	8618109*PED	2026-10-12		Pediatric extension
N205422-002	9839637*PED	2026-10-12		Pediatric extension
N205422-002	RE48059	2028-12-23		Drug substance	2020-07-20
N205422-002	RE48059*PED	2029-06-23		Pediatric extension
N205422-002	10307419	2032-10-12		Drug product	2019-06-14
N205422-002	10307419*PED	2033-04-12		Pediatric extension
N205422-003	8349840	2026-04-12	U-1529	Drug product	2015-07-23
N205422-003	8618109	2026-04-12	U-3281		2015-07-23
N205422-003	8618109	2026-04-12	U-543		2015-07-23
N205422-003	9839637	2026-04-12	U-1529	Drug product	2018-01-09
N205422-003	9839637	2026-04-12	U-3281	Drug product	2018-01-09
N205422-003	9839637	2026-04-12	U-543	Drug product	2018-01-09
N205422-003	8349840*PED	2026-10-12		Pediatric extension
N205422-003	8618109*PED	2026-10-12		Pediatric extension
N205422-003	9839637*PED	2026-10-12		Pediatric extension
N205422-003	RE48059	2028-12-23		Drug substance	2020-07-20
N205422-003	RE48059*PED	2029-06-23		Pediatric extension
N205422-003	10307419	2032-10-12		Drug product	2019-06-14
N205422-003	10307419*PED	2033-04-12		Pediatric extension
N205422-004	8349840	2026-04-12	U-1529	Drug product	2015-07-23
N205422-004	8618109	2026-04-12	U-3281		2015-07-23
N205422-004	8618109	2026-04-12	U-543		2015-07-23
N205422-004	9839637	2026-04-12	U-1529	Drug product	2018-01-09
N205422-004	9839637	2026-04-12	U-3281	Drug product	2018-01-09
N205422-004	9839637	2026-04-12	U-543	Drug product	2018-01-09
N205422-004	8349840*PED	2026-10-12		Pediatric extension
N205422-004	8618109*PED	2026-10-12		Pediatric extension
N205422-004	9839637*PED	2026-10-12		Pediatric extension
N205422-004	RE48059	2028-12-23		Drug substance	2020-07-20
N205422-004	RE48059*PED	2029-06-23		Pediatric extension
N205422-004	10307419	2032-10-12		Drug product	2019-06-14
N205422-004	10307419*PED	2033-04-12		Pediatric extension
N205422-005	8349840	2026-04-12	U-1529	Drug product	2015-07-23
N205422-005	8618109	2026-04-12	U-3281		2015-07-23
N205422-005	8618109	2026-04-12	U-543		2015-07-23
N205422-005	9839637	2026-04-12	U-1529	Drug product	2018-01-09
N205422-005	9839637	2026-04-12	U-3281	Drug product	2018-01-09
N205422-005	9839637	2026-04-12	U-543	Drug product	2018-01-09
N205422-005	8349840*PED	2026-10-12		Pediatric extension
N205422-005	8618109*PED	2026-10-12		Pediatric extension
N205422-005	9839637*PED	2026-10-12		Pediatric extension
N205422-005	RE48059	2028-12-23		Drug substance	2020-07-20
N205422-005	RE48059*PED	2029-06-23		Pediatric extension
N205422-005	10307419	2032-10-12		Drug product	2019-06-14
N205422-005	10307419*PED	2033-04-12		Pediatric extension
N205422-006	8349840	2026-04-12	U-1529	Drug product	2015-07-23
N205422-006	8618109	2026-04-12	U-3281		2015-07-23
N205422-006	8618109	2026-04-12	U-543		2015-07-23
N205422-006	9839637	2026-04-12	U-1529	Drug product	2018-01-09
N205422-006	9839637	2026-04-12	U-3281	Drug product	2018-01-09
N205422-006	9839637	2026-04-12	U-543	Drug product	2018-01-09
N205422-006	8349840*PED	2026-10-12		Pediatric extension
N205422-006	8618109*PED	2026-10-12		Pediatric extension
N205422-006	9839637*PED	2026-10-12		Pediatric extension
N205422-006	RE48059	2028-12-23		Drug substance	2020-07-20
N205422-006	RE48059*PED	2029-06-23		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 30 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205422-001	I-913	2026-05-10
N205422-001	PED	2026-11-10
N205422-001	M-14	2027-05-08
N205422-001	PED	2027-11-08
N205422-001	M-315	2028-05-09
N205422-002	I-913	2026-05-10
N205422-002	PED	2026-11-10
N205422-002	M-14	2027-05-08
N205422-002	PED	2027-11-08
N205422-002	M-315	2028-05-09
N205422-003	I-913	2026-05-10
N205422-003	PED	2026-11-10
N205422-003	M-14	2027-05-08
N205422-003	PED	2027-11-08
N205422-003	M-315	2028-05-09
N205422-004	I-913	2026-05-10
N205422-004	PED	2026-11-10
N205422-004	M-14	2027-05-08
N205422-004	PED	2027-11-08
N205422-004	M-315	2028-05-09
N205422-005	I-913	2026-05-10
N205422-005	PED	2026-11-10
N205422-005	M-14	2027-05-08
N205422-005	PED	2027-11-08
N205422-005	M-315	2028-05-09
N205422-006	I-913	2026-05-10
N205422-006	PED	2026-11-10
N205422-006	M-14	2027-05-08
N205422-006	PED	2027-11-08
N205422-006	M-315	2028-05-09

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 7 · 246 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
2026-02-19 14:30 UTC	2026-02	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205422-001	REXULTI	0.25MG	TABLET / ORAL		RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205422-002	REXULTI	0.5MG	TABLET / ORAL		RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205422-003	REXULTI	1MG	TABLET / ORAL		RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205422-004	REXULTI	2MG	TABLET / ORAL		RLD, RS	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205422-005	REXULTI	3MG	TABLET / ORAL		RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205422-006	REXULTI	4MG	TABLET / ORAL		RLD	2015-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205422-001	REXULTI	0.25MG	TABLET / ORAL		RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205422-002	REXULTI	0.5MG	TABLET / ORAL		RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205422-003	REXULTI	1MG	TABLET / ORAL		RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205422-004	REXULTI	2MG	TABLET / ORAL		RLD, RS	2015-07-10	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205422-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205422-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205422-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205422-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205422-006	AB	1	`b8a1b40f171c…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205422-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205422-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205422-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205422-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205422-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205422-006	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205422-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205422-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205422-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205422-004	AB	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 63 · 2,519 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	N205422-001	7888362	2026-04-12		Drug substance, Delist requested	2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	8349840	2026-04-12	U-1529	Drug product	2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	8618109	2026-04-12	U-543		2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	8618109	2026-04-12	U-3281		2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	9839637	2026-04-12	U-543	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	7888362*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	8349840*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	8618109*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	9839637*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	RE48059	2028-12-23		Drug substance	2020-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	RE48059*PED	2029-06-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	10307419	2032-10-12		Drug product	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	10307419*PED	2033-04-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	7888362	2026-04-12		Drug substance, Delist requested	2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	8349840	2026-04-12	U-1529	Drug product	2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	8618109	2026-04-12	U-543		2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	8618109	2026-04-12	U-3281		2015-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	9839637	2026-04-12	U-543	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	7888362*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	8349840*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	8618109*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	9839637*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	RE48059	2028-12-23		Drug substance	2020-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	RE48059*PED	2029-06-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	10307419	2032-10-12		Drug product	2019-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	10307419*PED	2033-04-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	7888362	2026-04-12		Drug substance, Delist requested	2015-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	8349840	2026-04-12	U-1529	Drug product	2015-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	8618109	2026-04-12	U-543		2015-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	8618109	2026-04-12	U-3281		2015-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	9839637	2026-04-12	U-543	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	7888362*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	8349840*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	8618109*PED	2026-10-12		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 16 · 612 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	N205422-001	I-913	2026-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	PED	2026-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	M-14	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	PED	2027-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-001	M-315	2028-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	I-913	2026-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	PED	2026-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	M-14	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	PED	2027-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-002	M-315	2028-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	I-913	2026-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	PED	2026-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	M-14	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	PED	2027-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-003	M-315	2028-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	I-913	2026-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	PED	2026-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	M-14	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	PED	2027-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-004	M-315	2028-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	I-913	2026-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	PED	2026-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	M-14	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	PED	2027-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-005	M-315	2028-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	I-913	2026-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	PED	2026-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	M-14	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	PED	2027-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205422-006	M-315	2028-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	I-913	2026-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	PED	2026-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	M-14	2027-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	PED	2027-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-001	M-315	2028-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	I-913	2026-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	PED	2026-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	M-14	2027-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	PED	2027-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205422-002	M-315	2028-05-09	`31067a03dcf5…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rexulti	BREXPIPRAZOLE	REMEDYREPACK INC.	6991c065-0f6e-433a-8f4f-796e0ece327f	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205422 application number: NDA205422 ndc (product): 70518-3548
Rexulti	BREXPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	2d301358-6291-4ec1-bd87-37b4ad9bd850	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205422 application number: NDA205422 ndc (product): 59148-038 ndc (product): 59148-037 ndc (product): 59148-039 ndc (product): 59148-040 ndc (product): 59148-036 ndc (product): 59148-035
Rexulti	BREXPIPRAZOLE	REMEDYREPACK INC.	df891816-3fdb-4347-8bf0-c18bc40f1d70	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205422 application number: NDA205422

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-035	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-035	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-036	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-037	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-038	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-039	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	REXULTI	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-040	Rexulti	brexpiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
70518-3548	Rexulti	brexpiprazole	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85830	SUPPL	2026-05-05
85829	SUPPL	2026-05-05
85815	SUPPL	2026-05-04
82192	SUPPL	2025-05-15
82207	SUPPL	2025-05-09
80568	SUPPL	2024-12-13
80559	SUPPL	2024-12-13
78441	SUPPL	2024-05-08
78424	SUPPL	2024-05-08
78423	SUPPL	2024-05-08
75554	SUPPL	2023-09-25
74217	SUPPL	2023-05-11
74213	SUPPL	2023-05-11
72283	SUPPL	2022-10-11
72274	SUPPL	2022-10-07
69796	SUPPL	2021-12-29
69792	SUPPL	2021-12-28
63642	SUPPL	2020-06-19
63641	SUPPL	2020-06-19
63626	SUPPL	2020-06-19
59103	ORIG	2019-06-17
59102	ORIG	2019-06-17
59101	ORIG	2019-06-17
52636	SUPPL	2018-02-14
52558	SUPPL	2018-02-12
52557	SUPPL	2018-02-12
47404	SUPPL	2017-03-02
47307	SUPPL	2017-02-24
45419	SUPPL	2016-09-29
45396	SUPPL	2016-09-26
43488	ORIG	2015-08-19
40466	ORIG	2015-07-13
10445	ORIG	2015-07-13