FDA.reportPublic FDA data

Sotylize 5 MG in 1 mL Oral Solution

RxCUI
1593731
RxNorm name
Sotylize 5 MG in 1 mL Oral Solution
Display name
Sotylize 5 MG in 1 mL Oral Solution
Full name
Sotylize 5 MG in 1 mL Oral Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

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
SOTYLIZESOTALOL HYDROCHLORIDEAzurity Pharmaceuticals, Inc.1f33f900-0777-4a92-a7f7-00cf3d57d95c2024-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1593731

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
1f33f900-0777-4a92-a7f7-00cf3d57d95cSotylize 5 MG in 1 mL Oral Solution [PSN] · sotalol hydrochloride 5 MG/ML Oral Solution [Sotylize] [SBD] · Sotylize 5 MG per 1 ML Oral Solution [SY]36These highlights do not include all the information needed to use SOTYLIZE ® safely and effectively. See full prescribing information for SOTYLIZE. SOTYLIZE (sotalol hydrochloride) oral solution Initial U.S. Approval: 199220240124