FDA.reportPublic FDA data

Lazcluze 80 MG Oral Tablet

RxCUI
2691162
RxNorm name
Lazcluze 80 MG Oral Tablet
Display name
Lazcluze 80 MG Oral Tablet
Full name
Lazcluze 80 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

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UNII Substances#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LAZCLUZELAZERTINIBJanssen Biotech, Inc.c417f9ee-2027-4ed5-92ad-3c19266de16c2026-05-05Warnings, Adverse reactionsExact identifier
rxcui: 2691162

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
c417f9ee-2027-4ed5-92ad-3c19266de16cLazcluze 80 MG Oral Tablet [PSN] · lazertinib 80 MG Oral Tablet [Lazcluze] [SBD] · Lazcluze 80 MG (equivalent to lazertinib mesylate 93.86 MG) Oral Tablet [SY] · Lazcluze 80 MG Oral Tablet [SY]46These highlights do not include all the information needed to use LAZCLUZE safely and effectively. See full prescribing information for LAZCLUZE. LAZCLUZE ® (lazertinib) tablets, for oral use Initial U.S. Approval: 202420260505