FDA.reportPublic FDA data

{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } Pack

RxCUI
2283535
RxNorm name
{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } Pack
Display name
{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } Pack
Full name
{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } Pack
Term type
GPCK
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XcopriCENOBAMATESK Life Science, Inc.565c2126-57ae-4e29-b443-723bbe7e20722025-08-25Warnings, Adverse reactionsExact identifier
rxcui: 2283535

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
565c2126-57ae-4e29-b443-723bbe7e2072{14 (cenobamate 100 MG Oral Tablet) / 14 (cenobamate 50 MG Oral Tablet) } Pack [GPCK] · cenobamate 50 MG Oral Tablet (14) / cenobamate 100 MG Oral Tablet (14) Titration Pack [PSN] · cenobamate 50 MG Oral Tablet (14) / cenobamate 100 MG Oral Tablet (14) Titration Pack [SY]343These highlights do not include all the information needed to use XCOPRI safely and effectively. See full prescribing information for XCOPRI. XCOPRI ® (cenobamate tablets), for oral use, CV Initial U.S. Approval: 202020250925