FDA.reportPublic FDA data

NDC 75833-800 - 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
75833-800
Package NDCs from labels
75833-800-01
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75833-800HEPZATO 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 158 of 197 · 3,926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDECamber Pharmaceuticals, Inc.24006cbf-4e91-4bb2-9627-25b4ebc9470a2024-06-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311487
Anti Bacterial Hand Gel Love Always WinsALCOHOLBath & Body Works, Inc.1b6a8105-53d2-8e0f-e063-6394a90a64af2024-06-21WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Kitchen MandarinALCOHOLBath & Body Works, Inc.1b2e5934-5914-2060-e063-6394a90ae0d32024-06-18WarningsExact identifier
unii: 3K9958V90M
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
Anti Bacterial Hand Gel Island MargaritaALCOHOLBath & Body Works, Inc.1ac7101d-bef1-7db6-e063-6294a90aca922024-06-13WarningsExact identifier
unii: 3K9958V90M
Derma Pain PlusCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOXICODENDRON, SARSAPARILLA (SMILAX REGELII)Peaceful Mountain, Inc.6fa79c31-e48e-4c83-baa2-96cef22cfee12024-06-13WarningsExact identifier
unii: 451W47IQ8X
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
unii: 451W47IQ8X
Anti Bacterial Hand Gel Gingham UnstoppableALCOHOLBath & Body Works, Inc.1ab80018-e9c2-a8eb-e063-6394a90a97f72024-06-12WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Gingham GlowALCOHOLBath & Body Works, Inc.1aa32eca-8cf6-75cb-e063-6294a90ab72b2024-06-12WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Iced Lemon Pound CakeALCOHOLBath & Body Works, Inc.1ab87e4e-828e-75dd-e063-6294a90a81212024-06-12WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel First SightALCOHOLBath & Body Works, Inc.1a9e9349-9495-81a5-e063-6294a90a7b7b2024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Flower ChildALCOHOLBath & Body Works, Inc.1a9ef8eb-325f-8c42-e063-6394a90a1ecc2024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Amalfi LemonALCOHOLBath & Body Works, Inc.1a9f2550-319d-ea51-e063-6394a90ab0aa2024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh Cut LilacsALCOHOLBath & Body Works, Inc.1a9f4c77-1afb-35f2-e063-6394a90a82b92024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Ghoul FriendALCOHOLBath & Body Works, Inc.1a9f6a23-1429-573d-e063-6394a90a0ea42024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel GinghamALCOHOLBath & Body Works, Inc.1aa2967a-d978-d294-e063-6294a90a25122024-06-11WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Danbury ShortbreadALCOHOLBath & Body Works, Inc.1a8e81c0-c97d-100c-e063-6394a90ab2072024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Diamond Of The SeasonALCOHOLBath & Body Works, Inc.1a8e710e-521f-2d66-e063-6394a90a80de2024-06-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Dressed In WhiteALCOHOLBath & Body Works, Inc.1a8eaa81-c110-69f1-e063-6394a90ab2642024-06-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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