FDA.reportPublic FDA data

entrectinib 100 MG Oral Capsule [Rozlytrek]

RxCUI
2197873
RxNorm name
entrectinib 100 MG Oral Capsule [Rozlytrek]
Display name
entrectinib 100 MG Oral Capsule [Rozlytrek]
Full name
entrectinib 100 MG Oral Capsule [Rozlytrek]
Term type
SBD
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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Reported adverse events (FAERS/openFDA)#

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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
c7c71b0c-2549-4495-86b6-c2807fa54908ROZLYTREK 100 MG Oral Capsule [PSN] · entrectinib 100 MG Oral Capsule [Rozlytrek] [SBD] · Rozlytrek 100 MG Oral Capsule [SY]318These highlights do not include all the information needed to use ROZLYTREK ® safely and effectively. See full prescribing information for ROZLYTREK. ROZLYTREK ® (entrectinib) capsules, for oral use ROZLYTREK ® (entrectinib) oral pellets Initial U.S. Approval: 201920251204