Rexulti

Product NDC: 70518-4608
11-digit product format: 705184608
Labeler code: 70518
Product ID: 70518-4608_5020a0aa-d8a3-5379-e063-6394a90aa65f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brexpiprazole
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA205422
Marketing category: NDA
Marketing start: 2026-04-22
Substance: BREXPIPRAZOLE
Active strength: 1 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
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 · 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 · 258 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	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	N205422-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205422-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-006	AB	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 67 · 2,671 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	N205422-001	8349840	2026-04-12	U-1529	Drug product	2015-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	8618109	2026-04-12	U-543		2015-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	8618109	2026-04-12	U-3281		2015-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	9839637	2026-04-12	U-543	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	8349840*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	8618109*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	9839637*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	RE48059	2028-12-23		Drug substance	2020-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	RE48059*PED	2029-06-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	10307419	2032-10-12		Drug product	2019-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	10307419*PED	2033-04-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	8349840	2026-04-12	U-1529	Drug product	2015-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	8618109	2026-04-12	U-543		2015-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	8618109	2026-04-12	U-3281		2015-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	9839637	2026-04-12	U-543	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	8349840*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	8618109*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	9839637*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	RE48059	2028-12-23		Drug substance	2020-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	RE48059*PED	2029-06-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	10307419	2032-10-12		Drug product	2019-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	10307419*PED	2033-04-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	8349840	2026-04-12	U-1529	Drug product	2015-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	8618109	2026-04-12	U-543		2015-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	8618109	2026-04-12	U-3281		2015-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	9839637	2026-04-12	U-543	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	8349840*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	8618109*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	9839637*PED	2026-10-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	RE48059	2028-12-23		Drug substance	2020-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	RE48059*PED	2029-06-23		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	10307419	2032-10-12		Drug product	2019-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	10307419*PED	2033-04-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	8349840	2026-04-12	U-1529	Drug product	2015-07-23	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 672 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	N205422-001	I-913	2026-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	PED	2026-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	M-14	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-001	M-315	2028-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	I-913	2026-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	PED	2026-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	M-14	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-002	M-315	2028-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	I-913	2026-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	PED	2026-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	M-14	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-003	M-315	2028-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	I-913	2026-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	PED	2026-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	M-14	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-004	M-315	2028-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	I-913	2026-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	PED	2026-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	M-14	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-005	M-315	2028-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	I-913	2026-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	PED	2026-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	M-14	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205422-006	M-315	2028-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205422-001	I-913	2026-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-001	PED	2026-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-001	M-14	2027-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-001	PED	2027-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-001	M-315	2028-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	I-913	2026-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	PED	2026-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	M-14	2027-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	PED	2027-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205422-002	M-315	2028-05-09	`caaa826d4ba7…`

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: Rexulti
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BREXPIPRAZOLE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2J3YBM1K8C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1658331	Internal RxNorm lookup
1658333	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
df891816-3fdb-4347-8bf0-c18bc40f1d70	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f98ce54-9f30-4e8a-8455-2d3e352e5314	Product name	2	20251106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4608-0	Rexulti	50 in 1 BOX	TABLET	50		1
70518-4608-1	Rexulti	1 in 1 POUCH	TABLET	1		1

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
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
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 (product): 70518-4608

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2J3YBM1K8C	BREXPIPRAZOLE	913611-97-9	BREXPIPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1658331	brexpiprazole 1 MG Oral Tablet	PSN	df891816-3fdb-4347-8bf0-c18bc40f1d70	1
1658333	REXULTI 1 MG Oral Tablet	PSN	df891816-3fdb-4347-8bf0-c18bc40f1d70	1
1658333	brexpiprazole 1 MG Oral Tablet [Rexulti]	SBD	df891816-3fdb-4347-8bf0-c18bc40f1d70	1
1658331	brexpiprazole 1 MG Oral Tablet	SCD	df891816-3fdb-4347-8bf0-c18bc40f1d70	1
1658333	Rexulti 1 MG Oral Tablet	SY	df891816-3fdb-4347-8bf0-c18bc40f1d70	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4608-0	70518460800	50 POUCH in 1 BOX (70518-4608-0) / 1 TABLET in 1 POUCH (70518-4608-1)	50 pouch	2026-04-22	No	No	Current
70518-4608-1	70518460801	1 in 1 POUCH					Historical