FDA.reportPublic FDA data

{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } Pack

RxCUI
2698135
RxNorm name
{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } Pack
Display name
{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } Pack
Full name
{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } Pack
Term type
GPCK
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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
LumryzSODIUM OXYBATEAvadel CNS Pharmaceuticals, LLC10e5e40c-52f3-4c73-8a34-2c29c690a9342025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2698135

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-52f3-4c73-8a34-2c29c690a934{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } Pack [GPCK] · sodium oxybate 28-Day Starter Pack [PSN] · sodium oxybate 28-Day Starter Pack [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