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#

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
RozlytrekENTRECTINIBGenentech, Inc.c7c71b0c-2549-4495-86b6-c2807fa549082025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 2197873

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