FDA.reportPublic FDA data

NDC 75833-444 - Hepzato Kit

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
75833-444
Package NDCs from labels
75833-444-01
Manufacturer
Delcath Systems, Inc.
Effective date
2026-06-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
melphalan hydrochloride injection, powder, lyophilized, for solutionDelcath Systems, Inc.2026-06-09HUMAN PRESCRIPTION DRUG LABEL
melphalan hydrochloride injection, powder, lyophilized, for solutionDelcath Systems, Inc.2025-09-04Risk Evaluation & Mitigation Strategies

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75833-444-01Hepzato Kit2 in 1 BOXINJECTION, SOLUTION0.9 mg in 100mL7
75833-444-01Hepzato Kit250 mL in 1 BAGINJECTION, SOLUTION500 mL0.9 mg in 100mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75833-444HEPZATO KIT (MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) KIT [DELCATH SYSTEMS, INC.]7Unmatched20250522_4f83c8f7-4cc0-4219-88d5-7cfddce91198.zip

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 99 of 198 · 3,951 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRESH FEELS HAND SANITIZER MIST COCONUT LIME SCENTETHYL ALCOHOLPearl World Inc.d47930c5-ea4e-43a5-8654-ca4f9d391c2d2025-10-06WarningsExact identifier
unii: 3K9958V90M
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA, Inc.b1c8e5d0-a766-4bf0-a385-b7b8940a0e2c2025-10-06WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.a0df14cd-50a3-48ba-8510-f04276793acc2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST OCEAN BREEZE SCENTETHYL ALCOHOLPearl World Inc.2d37bdef-2927-4d5c-906d-4f6563524cdd2025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA SUGAR SCENTETHYL ALCOHOLPearl World Inc.0c5c7939-b2ba-47b6-bb51-39920e320f952025-10-03WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.fd522416-b585-4426-ac0b-fb363d8ae5922025-10-03WarningsExact identifier
unii: 3K9958V90M
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X
FRESH FEELS HAND SANITIZER MIST SWEET PEONY SCENTETHYL ALCOHOLPearl World Inc.1fbe93d5-8af2-41ca-b516-98729655d2d42025-10-03WarningsExact identifier
unii: 3K9958V90M
Zylast AntisepticETHYL ALCOHOLInnovative BioDefense178190dc-7c68-6485-e054-00144ff8d46c2025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c77ae-e9ff-4656-e053-2995a90a16d42025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand SanitizerALCOHOLInnovative Biodefense, Incd91b6278-864e-477a-e053-2a95a90aabd92025-10-02WarningsExact identifier
unii: 3K9958V90M
CleanBoss Hand Sanitizing GelETHYL ALCOHOLInnovative Biodefensed91c5753-eb27-1d1c-e053-2a95a90a888a2025-10-02WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SCENTETHYL ALCOHOLPearl World Inc.36853a90-74fa-4427-814a-d703e68a6dde2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MIXED BERRY SCENTETHYL ALCOHOLPearl World Inc.f48def31-3a9c-49fb-817b-5fca781ad88a2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SCENTETHYL ALCOHOLPearl World Inc.70963fc5-926c-446a-abe6-b828436255db2025-10-01WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY SCENTETHYL ALCOHOLPearl World Inc.3e77d397-ef6c-4898-8e87-31023b44dc362025-10-01WarningsExact identifier
unii: 3K9958V90M
Fresh Feels Hand Sanitizer MistFRESH FEELS HAND SANITIZER MISTZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3ffda86b-6b1d-8f0d-e063-6394a90aafaf2025-09-30WarningsExact identifier
unii: 3K9958V90M
Lavender Hand Sanitizer WipesETHANOLWhole Foods Market, Inc.0398573a-44fa-e0c6-e063-6394a90a99242025-09-30WarningsExact identifier
unii: 3K9958V90M
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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