FDA.reportPublic FDA data

ROZLYTREK 200 MG Oral Capsule

RxCUI
2197877
RxNorm name
ROZLYTREK 200 MG Oral Capsule
Display name
ROZLYTREK 200 MG Oral Capsule
Full name
ROZLYTREK 200 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:20

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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
RozlytrekENTRECTINIBGenentech, Inc.c7c71b0c-2549-4495-86b6-c2807fa549082025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 2197877

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 200 MG Oral Capsule [PSN] · entrectinib 200 MG Oral Capsule [Rozlytrek] [SBD] · Rozlytrek 200 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