FDA.reportPublic FDA data

larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsule

RxCUI
2105633
RxNorm name
larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsule
Display name
larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsule
Full name
larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VITRAKVILAROTRECTINIBBayer HealthCare Pharmaceuticals Inc.0c8ca614-58b2-4aa4-83d3-0387a8f782fd2026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 2105633
VITRAKVILAROTRECTINIBLoxo Oncology, Inc.9525f887-a055-4e33-8e92-898d42828cd12018-12-05Warnings, Adverse reactionsExact identifier
rxcui: 2105633

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0c8ca614-58b2-4aa4-83d3-0387a8f782fdlarotrectinib 100 MG Oral CapsuleSCD21These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 201820260522
0c8ca614-58b2-4aa4-83d3-0387a8f782fdlarotrectinib 100 MG Oral CapsulePSN21These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 201820260522
0c8ca614-58b2-4aa4-83d3-0387a8f782fdlarotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsuleSY21These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 201820260522
9525f887-a055-4e33-8e92-898d42828cd1larotrectinib 100 MG Oral CapsulePSN3These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 201820181205
9525f887-a055-4e33-8e92-898d42828cd1larotrectinib 100 MG Oral CapsuleSCD3These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 201820181205
9525f887-a055-4e33-8e92-898d42828cd1larotrectinib 100 MG (as 123 MG larotrectinib sulfate) oral capsuleSY3These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI ® (larotrectinib) capsules, for oral use VITRAKVI ® (larotrectinib) oral solution Initial U.S. Approval: 201820181205