FDA.reportPublic FDA data

topotecan 1 MG/ML Injectable Solution

RxCUI
637549
RxNorm name
topotecan 1 MG/ML Injectable Solution
Display name
topotecan 1 MG/ML Injectable Solution
Full name
topotecan 1 MG/ML Injectable Solution
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:04

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopotecanTOPOTECANAccord Healthcare Inc.7636bc1e-77b6-46ad-9df0-c8bb1c5e503f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 637549

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
7636bc1e-77b6-46ad-9df0-c8bb1c5e503ftopotecan 1 MG/ML Injectable Solution [PSN] · topotecan 1 MG/ML Injectable Solution [SCD] · topotecan (as topotecan hydrochloride) 1 MG/ML Injectable Solution [SY]38These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. TOPOTECAN Injection Must be diluted before intravenous infusion Initial U.S. Approval: 199620251217