FDA.reportPublic FDA data

fitusiran 20 MG per 0.2 ML Injection

RxCUI
2709452
RxNorm name
fitusiran 20 MG per 0.2 ML Injection
Display name
fitusiran 20 MG per 0.2 ML Injection
Full name
fitusiran 20 MG per 0.2 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

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
QfitliaFITUSIRANGenzyme Corporation6dd2f8ac-6f90-4cbf-b197-97d74964135c2025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709452

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
6dd2f8ac-6f90-4cbf-b197-97d74964135cfitusiran 20 MG in 0.2 ML Injection [PSN] · 0.2 ML fitusiran 100 MG/ML Injection [SCD] · fitusiran 20 MG per 0.2 ML Injection [SY]36These highlights do not include all the information needed to use QFITLIA ® safely and effectively. See full prescribing information for QFITLIA. QFITLIA (fitusiran) injection, for subcutaneous use Initial U.S. Approval: 202520250916