BREXPIPRAZOLE - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2025-11-06
Label type: Indexing - product concept
Version: 2
Source: full-release
Hydrated at: 2026-06-05 00:26:26

Label at a glance#

ProductBREXPIPRAZOLE

Active ingredientBREXPIPRAZOLE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

BREXPIPRAZOLE

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BREXPIPRAZOLE	2J3YBM1K8C	ACTIB
BREXPIPRAZOLE	2J3YBM1K8C	ACTIB
BREXPIPRAZOLE	2J3YBM1K8C	ACTIB
BREXPIPRAZOLE	2J3YBM1K8C	ACTIB
BREXPIPRAZOLE	2J3YBM1K8C	ACTIB
BREXPIPRAZOLE	2J3YBM1K8C	ACTIB

Source Document#

Source XML

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	Name fallback generic name: BREXPIPRAZOLE
Rexulti	BREXPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	2d301358-6291-4ec1-bd87-37b4ad9bd850	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BREXPIPRAZOLE
Brexpiprazole	BREXPIPRAZOLE	Ajanta Pharma USA Inc.	993b584c-7fe6-4551-899f-39146c8508ac	2022-12-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Brexpiprazole generic name: BREXPIPRAZOLE

Reported adverse events (FAERS/openFDA)#

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