FDA.reportPublic FDA data

0.8 ML eplontersen 56.3 MG/ML Auto-Injector [Wainua]

RxCUI
2671950
RxNorm name
0.8 ML eplontersen 56.3 MG/ML Auto-Injector [Wainua]
Display name
0.8 ML eplontersen 56.3 MG/ML Auto-Injector [Wainua]
Full name
0.8 ML eplontersen 56.3 MG/ML Auto-Injector [Wainua]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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
WAINUAEPLONTERSENAstraZeneca Pharmaceuticals LPd7dcb847-71dd-4fff-82d0-d43a465fc0962026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 2671950

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
d7dcb847-71dd-4fff-82d0-d43a465fc096WAINUA 45 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML eplontersen 56.3 MG/ML Auto-Injector [Wainua] [SBD] · Wainua 45 MG (as eplontersen sodium 47 MG) per 0.8 ML Auto-Injector [SY] · Wainua 56.25 MG/ML per 0.8 ML Auto-Injector [SY]420These highlights do not include all the information needed to use WAINUA safely and effectively. See full prescribing information for WAINUA. WAINUA ® (eplontersen) injection, for subcutaneous use Initial U.S. Approval: 202320260415