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 121 of 197 · 3,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
unii: 3K9958V90M
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
unii: 3K9958V90M
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsExact identifier
unii: 3K9958V90M
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsExact identifier
unii: 3K9958V90M
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsExact identifier
unii: 3K9958V90M
meijer GINGERBREAD SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.1e1c8847-2d9e-43a6-9dd4-06c094c57c7b2025-03-28WarningsExact identifier
unii: 3K9958V90M
Symmetry Foaming Hand SanitizerALCOHOLBuckeye International, Inc.1cfcad5c-3896-3f69-e063-6294a90a8d9e2025-03-27WarningsExact identifier
unii: 3K9958V90M
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.1cfe0fba-69a0-6eb8-e063-6294a90a05822025-03-27WarningsExact identifier
unii: 3K9958V90M
Symmetry Foaming Hand Sanitizer Fragrance FreeALCOHOLBuckeye International, Inc.1ce8bcc4-9b1a-1464-e063-6294a90a1e9e2025-03-27WarningsExact identifier
unii: 3K9958V90M
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsExact identifier
unii: 3K9958V90M
Caring Mill Hand Advanced SanitizerETHYL ALCOHOL 70%Veridian Healthcare312e0fde-8b5b-1296-e063-6294a90a4f262025-03-25WarningsExact identifier
unii: 3K9958V90M
Symmetry Foaming Hand Sanitizer-Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.00a2c2b4-b540-4acc-86b9-b4dfb4e8695b2025-03-25Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Altra Foaming Hand Sanitizer with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a28ff21e-a507-8257-e053-2a95a90afd4e2025-03-25WarningsExact identifier
unii: 3K9958V90M
Altra Foaming Hand Sanitizer Fragrance Free with Aloe and Vitamin EALCOHOLBuckeye International, Inc.a2963c01-55f7-a3cc-e053-2a95a90a72c62025-03-25WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZING WIPESHAND SANITIZING WIPESIMAGINE AMAZON LLC30a373d6-59cd-fc74-e063-6394a90a9a9a2025-03-24WarningsExact identifier
unii: 3K9958V90M
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Walgreens WATERMELON Hand Sanitizer MistETHYL ALCOHOLWalgreen Company17cc5de6-8046-4972-a280-ff7cabbb73c02025-03-21WarningsExact identifier
unii: 3K9958V90M
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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