FDA.reportPublic FDA data

ganaxolone 50 MG in 1 mL Oral Suspension

RxCUI
2604694
RxNorm name
ganaxolone 50 MG in 1 mL Oral Suspension
Display name
ganaxolone 50 MG in 1 mL Oral Suspension
Full name
ganaxolone 50 MG in 1 mL Oral Suspension
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

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
ZTALMYGANAXOLONEImmedica Pharma US Incd91612c4-b03a-4be4-a1ee-6a13e3b83d4e2025-11-28Warnings, Adverse reactionsExact identifier
rxcui: 2604694

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
d91612c4-b03a-4be4-a1ee-6a13e3b83d4eganaxolone 50 MG in 1 mL Oral Suspension [PSN] · ganaxolone 50 MG/ML Oral Suspension [SCD] · ganaxolone 50 MG per 1 ML Oral Suspension [SY]313These highlights do not include all the information needed to use ZTALMY ® safely and effectively. See full prescribing information for ZTALMY. ZTALMY ® (ganaxolone) oral suspension, CV Initial U.S. Approval: 202220251128