FDA.reportPublic FDA data

1.5 ML TSPA 10 MG/ML Injection [Tepylute]

RxCUI
2700712
RxNorm name
1.5 ML TSPA 10 MG/ML Injection [Tepylute]
Display name
1.5 ML TSPA 10 MG/ML Injection [Tepylute]
Full name
1.5 ML TSPA 10 MG/ML Injection [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: 2700712

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 15 MG in 1.5 ML Injection [PSN] · 1.5 ML thiotepa 10 MG/ML Injection [Tepylute] [SBD] · 1.5 ML TSPA 10 MG/ML Injection [Tepylute] [SY] · Tepylute 10 MG/ML per 1.5 ML Injection [SY] · Tepylute 15 MG per 1.5 ML Injection [SY]54These 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