FDA.reportPublic FDA data

inotersen 284 MG per 1.5 ML Prefilled Syringe

RxCUI
2099318
RxNorm name
inotersen 284 MG per 1.5 ML Prefilled Syringe
Display name
inotersen 284 MG per 1.5 ML Prefilled Syringe
Full name
inotersen 284 MG per 1.5 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

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.

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8513207e-b55f-417b-9473-af785146a543inotersen 284 MG in 1.5 mL Prefilled Syringe [PSN] · 1.5 ML inotersen 189 MG/ML Prefilled Syringe [SCD] · inotersen 189 MG/ML per 1.5 ML Prefilled Syringe [SY] · inotersen 284 MG per 1.5 ML Prefilled Syringe [SY]410These highlights do not include all the information needed to use TEGSEDI ® safely and effectively. See full prescribing information for TEGSEDI. TEGSEDI (inotersen) injection, for subcutaneous use Initial U.S. Approval: 201820240125
3d31f4c0-35bb-c990-e063-6394a90a749finotersen 284 MG in 1.5 mL Prefilled Syringe [PSN] · 1.5 ML inotersen 189 MG/ML Prefilled Syringe [SCD] · inotersen 189 MG/ML per 1.5 ML Prefilled Syringe [SY] · inotersen 284 MG per 1.5 ML Prefilled Syringe [SY]41139-105-300 EXP20250813