FDA.reportPublic FDA data

Ztalmy 50 MG in 1 mL Oral Suspension

RxCUI
2604700
RxNorm name
Ztalmy 50 MG in 1 mL Oral Suspension
Display name
Ztalmy 50 MG in 1 mL Oral Suspension
Full name
Ztalmy 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#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZTALMYGANAXOLONEImmedica Pharma US Incd91612c4-b03a-4be4-a1ee-6a13e3b83d4e2025-11-28Warnings, Adverse reactionsExact identifier
rxcui: 2604700

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-6a13e3b83d4eZtalmy 50 MG in 1 mL Oral Suspension [PSN] · ganaxolone 50 MG/ML Oral Suspension [Ztalmy] [SBD] · Ztalmy 50 MG per 1 ML Oral Suspension [SY] · Ztalmy 50 MG/ML Oral Suspension [SY]413These 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