FDA.reportPublic FDA data

Lutathera 7.4 GBq per 25 ML Injection

RxCUI
1999687
RxNorm name
Lutathera 7.4 GBq per 25 ML Injection
Display name
Lutathera 7.4 GBq per 25 ML Injection
Full name
Lutathera 7.4 GBq per 25 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

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
LutatheraLUTETIUM LU 177 DOTATATEAdvanced Accelerator Applications USA, Inc72d1a024-00b7-418a-b36e-b2cb48f2ab552026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 1999687

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
72d1a024-00b7-418a-b36e-b2cb48f2ab55LUTATHERA 370 MBq/mL Injection [PSN] · 25 ML lutetium Lu 177 dotatate 10 MCI/ML Injection [Lutathera] [SBD] · Lutathera 200 mCi per 25 ML Injection [SY] · Lutathera 7.4 GBq per 25 ML Injection [SY]412These highlights do not include all the information needed to use LUTATHERA safely and effectively. See full prescribing information for LUTATHERA. LUTATHERA ® (lutetium Lu 177 dotatate) injection, for intravenous use Initial U.S. Approval: 201820260115