FDA.reportPublic FDA data

Dawnzera 80 MG per 0.8 ML Auto-Injector

RxCUI
2724453
RxNorm name
Dawnzera 80 MG per 0.8 ML Auto-Injector
Display name
Dawnzera 80 MG per 0.8 ML Auto-Injector
Full name
Dawnzera 80 MG per 0.8 ML Auto-Injector
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAWNZERADONIDALORSENIonis Pharmaceuticals Inc.3ff501e0-f75f-07da-e063-6294a90a0cb72025-09-24Warnings, Adverse reactionsExact identifier
rxcui: 2724453

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
3ff501e0-f75f-07da-e063-6294a90a0cb7DAWNZERA 80 MG in 0.8 ML Auto-Injector [PSN] · 0.8 ML donidalorsen 100 MG/ML Auto-Injector [Dawnzera] [SBD] · Dawnzera 80 MG (equivalent to donidalorsen sodium 84 MG) per 0.8 ML Auto-Injector [SY] · Dawnzera 80 MG per 0.8 ML Auto-Injector [SY]41These highlights do not include all the information needed to use DAWNZERA™ (donidalorsen) safely and effectively. See full prescribing information for DAWNZERA. DAWNZERA™ (donidalorsen) injection, for subcutaneous use Initial U.S. Approval: 202520250924