FDA.reportPublic FDA data

Hepzato 50 MG Injection

RxCUI
2671196
RxNorm name
Hepzato 50 MG Injection
Display name
Hepzato 50 MG Injection
Full name
Hepzato 50 MG Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:58

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
Hepzato KitMELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONDelcath Systems, Inc.4f83c8f7-4cc0-4219-88d5-7cfddce911982026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2671196

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
4f83c8f7-4cc0-4219-88d5-7cfddce91198HEPZATO 50 MG Injection [PSN] · melphalan 50 MG Injection [Hepzato] [SBD] · Hepzato 50 MG Injection [SY]37These highlights do not include all the information needed to use HEPZATO safely and effectively. See full prescribing information for HEPZATO KIT and HEPZATO KIT Hepatic Delivery System Instructions for Use. HEPZATO (melphalan) for injection is a component of the HEPZATO KIT Hepatic Delivery System (HDS) for intra-arterial use. Initial U.S. Approval: 196420250519