FDA.reportPublic FDA data

TSPA 10 MG/ML Injectable Solution [Tepylute]

RxCUI
2709442
RxNorm name
TSPA 10 MG/ML Injectable Solution [Tepylute]
Display name
TSPA 10 MG/ML Injectable Solution [Tepylute]
Full name
TSPA 10 MG/ML Injectable Solution [Tepylute]
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

RxNav Current And Historical NDCs#

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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
TEPYLUTETHIOTEPAShorla Oncology Inc.add44e98-a042-4e38-b870-beb36693805b2025-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709442

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
add44e98-a042-4e38-b870-beb36693805bTepylute 10 MG/ML Injectable Solution [PSN] · thiotepa 10 MG/ML Injectable Solution [Tepylute] [SBD] · Tepylute 10 MG per 1 ML Injectable Solution [SY] · TSPA 10 MG/ML Injectable Solution [Tepylute] [SY]44These highlights do not include all the information needed to use TEPYLUTE ® safely and effectively. See full prescribing information for TEPYLUTE ® . TEPYLUTE ® (thiotepa) injection, for intravenous use Initial U.S. Approval: 195920250701