FDA.reportPublic FDA data

gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet

RxCUI
2672388
RxNorm name
gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet
Display name
gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet
Full name
gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

RxNav Current And Historical NDCs#

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UNII Substances#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXXUAGEPIRONEAytu Therapeutics, LLC0c78edd8-6acb-433c-9d34-2527da8d64e12026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2672388

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
0c78edd8-6acb-433c-9d34-2527da8d64e1gepirone 54.5 MG 24 HR Extended Release Oral Tablet [PSN] · 24 HR gepirone 54.5 MG Extended Release Oral Tablet [SCD] · gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral Tablet [SY]32These highlights do not include all the information needed to use EXXUA ™ safely and effectively. See full prescribing information for EXXUA . EXXUA ( gepirone ) extended-release tablets for oral use Initial U.S. Approval: 202320251016