Rexulti

Product NDC: 59148-038
11-digit product format: 591480038
Labeler code: 59148
Product ID: 59148-038_3a208135-0d99-4d6a-b73e-61d63cf48f4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brexpiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA205422
Marketing category: NDA
Marketing start: 2015-07-10
Substance: BREXPIPRAZOLE
Active strength: 2 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 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.

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
2026-08-01 22:54:32	2026-06	N205422-001	REXULTI	0.25MG	TABLET / ORAL	AB	RLD	2015-07-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	REXULTI	0.5MG	TABLET / ORAL	AB	RLD	2015-07-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	REXULTI	1MG	TABLET / ORAL	AB	RLD	2015-07-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	REXULTI	2MG	TABLET / ORAL	AB	RLD, RS	2015-07-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	REXULTI	3MG	TABLET / ORAL	AB	RLD	2015-07-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	REXULTI	4MG	TABLET / ORAL	AB	RLD	2015-07-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N205422-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N205422-001	8349840	2026-04-12	U-1529	Drug product	2015-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	8618109	2026-04-12	U-543		2015-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	8618109	2026-04-12	U-3281		2015-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	9839637	2026-04-12	U-543	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	8349840*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	8618109*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	9839637*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	RE48059	2028-12-23		Drug substance	2020-07-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	RE48059*PED	2029-06-23		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	10307419	2032-10-12		Drug product	2019-06-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	10307419*PED	2033-04-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	8349840	2026-04-12	U-1529	Drug product	2015-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	8618109	2026-04-12	U-543		2015-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	8618109	2026-04-12	U-3281		2015-07-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	9839637	2026-04-12	U-543	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	8349840*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	8618109*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	9839637*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	RE48059	2028-12-23		Drug substance	2020-07-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	RE48059*PED	2029-06-23		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	10307419	2032-10-12		Drug product	2019-06-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	10307419*PED	2033-04-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	8349840	2026-04-12	U-1529	Drug product	2015-07-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	8618109	2026-04-12	U-543		2015-07-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	8618109	2026-04-12	U-3281		2015-07-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	9839637	2026-04-12	U-1529	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	9839637	2026-04-12	U-543	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	9839637	2026-04-12	U-3281	Drug product	2018-01-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	8349840*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	8618109*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	9839637*PED	2026-10-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	RE48059	2028-12-23		Drug substance	2020-07-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	RE48059*PED	2029-06-23		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	10307419	2032-10-12		Drug product	2019-06-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	10307419*PED	2033-04-12		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	8349840	2026-04-12	U-1529	Drug product	2015-07-23	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N205422-001	I-913	2026-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	PED	2026-11-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	M-14	2027-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	PED	2027-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-001	M-315	2028-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	I-913	2026-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	PED	2026-11-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	M-14	2027-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	PED	2027-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-002	M-315	2028-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	I-913	2026-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	PED	2026-11-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	M-14	2027-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	PED	2027-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-003	M-315	2028-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	I-913	2026-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	PED	2026-11-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	M-14	2027-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	PED	2027-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-004	M-315	2028-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	I-913	2026-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	PED	2026-11-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	M-14	2027-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	PED	2027-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-005	M-315	2028-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	I-913	2026-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	PED	2026-11-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	M-14	2027-05-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	PED	2027-11-08	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N205422-006	M-315	2028-05-09	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 59148-038
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BREXPIPRAZOLE	2 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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1658319	Internal RxNorm lookup
1658325	Internal RxNorm lookup
1658327	Internal RxNorm lookup
1658329	Internal RxNorm lookup
1658331	Internal RxNorm lookup
1658333	Internal RxNorm lookup
1658335	Internal RxNorm lookup
1658337	Internal RxNorm lookup
1658339	Internal RxNorm lookup
1658341	Internal RxNorm lookup
1658343	Internal RxNorm lookup
1658345	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
2d301358-6291-4ec1-bd87-37b4ad9bd850	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59148-038-13	2021-07-27	C162847	48780-1	c7ccaba7-155a-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use REXULTI safely and effectively. See full prescribing information for REXULTI. REXULTI® (brexpiprazole) tablets, for oral use Initial U.S. Approval: 2015
59148-038-13	2021-07-23	C162847	48780-1	c7ccaba7-155a-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use REXULTI safely and effectively. See full prescribing information for REXULTI. REXULTI® (brexpiprazole) tablets, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59148-038-07	Rexulti	7 in 1 BLISTER PACK	TABLET	7	26
59148-038-07	Rexulti	1 in 1 CARTON	TABLET	1	26
59148-038-13	Rexulti	30 in 1 BOTTLE	TABLET	30	26
59148-038-13	Rexulti	1 in 1 CARTON	TABLET	1	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-038-13	EA - Each	59148-038	d27f1710-e671-4aa4-aff7-e5f20e526fd4	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
brexpiprazole	ACTIVE INGREDIENT	2J3YBM1K8C	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
brexpiprazole	ACTIVE MOIETY	2J3YBM1K8C	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
hydroxypropyl cellulose, low substituted	INACTIVE INGREDIENT	2165RE0K14	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-038	REXULTI (BREXPIPRAZOLE) TABLET REXULTI (BREXPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.]	24	Current NDC, Legacy NDC, 4 package rows	20250519_2d301358-6291-4ec1-bd87-37b4ad9bd850.zip

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
1658319	brexpiprazole 0.25 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658327	brexpiprazole 0.5 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658331	brexpiprazole 1 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658335	brexpiprazole 2 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658339	brexpiprazole 3 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658343	brexpiprazole 4 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658325	REXULTI 0.25 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658329	REXULTI 0.5 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658333	REXULTI 1 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658337	REXULTI 2 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658341	REXULTI 3 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658345	REXULTI 4 MG Oral Tablet	PSN	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658325	brexpiprazole 0.25 MG Oral Tablet [Rexulti]	SBD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658329	brexpiprazole 0.5 MG Oral Tablet [Rexulti]	SBD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658333	brexpiprazole 1 MG Oral Tablet [Rexulti]	SBD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658337	brexpiprazole 2 MG Oral Tablet [Rexulti]	SBD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658341	brexpiprazole 3 MG Oral Tablet [Rexulti]	SBD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658345	brexpiprazole 4 MG Oral Tablet [Rexulti]	SBD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658319	brexpiprazole 0.25 MG Oral Tablet	SCD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658327	brexpiprazole 0.5 MG Oral Tablet	SCD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658331	brexpiprazole 1 MG Oral Tablet	SCD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658335	brexpiprazole 2 MG Oral Tablet	SCD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658339	brexpiprazole 3 MG Oral Tablet	SCD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658343	brexpiprazole 4 MG Oral Tablet	SCD	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658325	Rexulti 0.25 MG Oral Tablet	SY	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658329	Rexulti 0.5 MG Oral Tablet	SY	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658333	Rexulti 1 MG Oral Tablet	SY	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658337	Rexulti 2 MG Oral Tablet	SY	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658341	Rexulti 3 MG Oral Tablet	SY	2d301358-6291-4ec1-bd87-37b4ad9bd850	26
1658345	Rexulti 4 MG Oral Tablet	SY	2d301358-6291-4ec1-bd87-37b4ad9bd850	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59148-038-07	59148003807	1 BLISTER PACK in 1 CARTON (59148-038-07) / 7 TABLET in 1 BLISTER PACK	1 blister pack	2015-07-10		Yes	No	Current
59148-038-13	59148003813	1 BOTTLE in 1 CARTON (59148-038-13) / 30 TABLET in 1 BOTTLE	1 bottle	2015-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rexulti	REMEDYREPACK INC.	2026-06-02	HUMAN PRESCRIPTION DRUG LABEL	6
Rexulti	Otsuka America Pharmaceutical, Inc.	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	26