FDA.reportPublic FDA data

topotecan 4 MG Injection

RxCUI
1799416
RxNorm name
topotecan 4 MG Injection
Display name
topotecan 4 MG Injection
Full name
topotecan 4 MG Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topotecan HydrochlorideTOPOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCb6019088-cd94-43b4-b5ce-ba20b6b8021e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1799416
topotecan hydrochlorideTOPOTECAN HYDROCHLORIDEAccord Healthcare, Inc.729b2b22-1344-44f3-b614-14f6ec3c263e2024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1799416
Topotecan hydrochlorideTOPOTECAN HYDROCHLORIDEActavis Pharma, Inc.996430c0-ee26-4ed9-82b8-a8b645becba62022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1799416
HYCAMTINTOPOTECAN HYDROCHLORIDENovartis Pharmaceuticals Corporationeeee060c-a9ec-423e-a374-8484009f85242022-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1799416

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b6019088-cd94-43b4-b5ce-ba20b6b8021etopotecan 4 MG InjectionPSN15These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620260114
b6019088-cd94-43b4-b5ce-ba20b6b8021etopotecan (as topotecan hydrochloride) 4 MG InjectionSY15These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620260114
b6019088-cd94-43b4-b5ce-ba20b6b8021etopotecan 4 MG InjectionSCD15These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620260114
729b2b22-1344-44f3-b614-14f6ec3c263etopotecan 4 MG InjectionPSN10These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection , for intravenous use Initial U.S. Approval: 199620241004
729b2b22-1344-44f3-b614-14f6ec3c263etopotecan (as topotecan hydrochloride) 4 MG InjectionSY10These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection , for intravenous use Initial U.S. Approval: 199620241004
729b2b22-1344-44f3-b614-14f6ec3c263etopotecan 4 MG InjectionSCD10These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection , for intravenous use Initial U.S. Approval: 199620241004
996430c0-ee26-4ed9-82b8-a8b645becba6topotecan 4 MG InjectionPSN10These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620220831
996430c0-ee26-4ed9-82b8-a8b645becba6topotecan 4 MG InjectionSCD10These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620220831
996430c0-ee26-4ed9-82b8-a8b645becba6topotecan (as topotecan hydrochloride) 4 MG InjectionSY10These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620220831
eeee060c-a9ec-423e-a374-8484009f8524topotecan 4 MG InjectionPSN8These highlights do not include all the information needed to use HYCAMTIN FOR INJECTION safely and effectively. See full prescribing information for HYCAMTIN FOR INJECTION. HYCAMTIN ® (topotecan) for injection, for intravenous use Initial U.S. Approval: 199620220707
eeee060c-a9ec-423e-a374-8484009f8524topotecan 4 MG InjectionSCD8These highlights do not include all the information needed to use HYCAMTIN FOR INJECTION safely and effectively. See full prescribing information for HYCAMTIN FOR INJECTION. HYCAMTIN ® (topotecan) for injection, for intravenous use Initial U.S. Approval: 199620220707
eeee060c-a9ec-423e-a374-8484009f8524topotecan (as topotecan hydrochloride) 4 MG InjectionSY8These highlights do not include all the information needed to use HYCAMTIN FOR INJECTION safely and effectively. See full prescribing information for HYCAMTIN FOR INJECTION. HYCAMTIN ® (topotecan) for injection, for intravenous use Initial U.S. Approval: 199620220707
a439bf07-53db-0352-846a-99d9da772f9btopotecan (as topotecan hydrochloride) 4 MG InjectionSY5These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 199620160428
a439bf07-53db-0352-846a-99d9da772f9btopotecan 4 MG InjectionPSN5These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 199620160428
a439bf07-53db-0352-846a-99d9da772f9btopotecan 4 MG InjectionSCD5These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 199620160428
207ee628-1a7a-4949-bab2-07b9d79b72a3topotecan 4 MG InjectionSCD2These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620191115
207ee628-1a7a-4949-bab2-07b9d79b72a3topotecan (as topotecan hydrochloride) 4 MG InjectionSY2These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620191115
207ee628-1a7a-4949-bab2-07b9d79b72a3topotecan 4 MG InjectionPSN2These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN HYDROCHLORIDE for injection, for intravenous use Initial U.S. Approval: 199620191115