FDA.reportPublic FDA data

sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension

RxCUI
2636822
RxNorm name
sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension
Display name
sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension
Full name
sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
LumryzSODIUM OXYBATEAvadel CNS Pharmaceuticals, LLC10e5e40c-52f3-4c73-8a34-2c29c690a9342025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2636822

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
10e5e40c-52f3-4c73-8a34-2c29c690a934sodium oxybate 4.5 GM Granules for extended release Oral Suspension [PSN] · sodium oxybate 4500 MG Granules for Oral Suspension [SCD] · sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension [SY]310These highlights do not include all the information needed to use LUMRYZ™ safely and effectively. See full prescribing information for LUMRYZ. LUMRYZ (sodium oxybate) for extended-release oral suspension, CIII Initial U.S. Approval: 200220251204