FDA.reportPublic FDA data

brexpiprazole 2 MG Oral Tablet [Rexulti]

RxCUI
1658337
RxNorm name
brexpiprazole 2 MG Oral Tablet [Rexulti]
Display name
brexpiprazole 2 MG Oral Tablet [Rexulti]
Full name
brexpiprazole 2 MG Oral Tablet [Rexulti]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RexultiBREXPIPRAZOLEREMEDYREPACK INC.6991c065-0f6e-433a-8f4f-796e0ece327f2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1658337
RexultiBREXPIPRAZOLEOtsuka America Pharmaceutical, Inc.2d301358-6291-4ec1-bd87-37b4ad9bd8502026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1658337

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2d301358-6291-4ec1-bd87-37b4ad9bd850REXULTI 2 MG Oral Tablet [PSN] · brexpiprazole 2 MG Oral Tablet [Rexulti] [SBD] · Rexulti 2 MG Oral Tablet [SY]326These 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: 201520260506