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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7636bc1e-77b6-46ad-9df0-c8bb1c5e503ftopotecan 1 MG/ML Injectable SolutionPSN8These 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
7636bc1e-77b6-46ad-9df0-c8bb1c5e503ftopotecan 1 MG/ML Injectable SolutionSCD8These 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
7636bc1e-77b6-46ad-9df0-c8bb1c5e503ftopotecan (as topotecan hydrochloride) 1 MG/ML Injectable SolutionSY8These 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