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 135 of 197 · 3,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC49309411-9af4-4f19-a3bf-dbeabc1068272024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLCba0868f6-d3de-40e2-bcb3-144fa53062c72024-12-23WarningsExact identifier
unii: 451W47IQ8X
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC9d83f477-ebbc-4248-8445-769178181d4f2024-12-23WarningsExact identifier
unii: 451W47IQ8X
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
MedBox Hand SanitizerALCOHOLHarpers Pharmacy, Inc.f66c6abe-161c-48fa-8736-0abf97c3799a2024-12-20WarningsExact identifier
unii: 3K9958V90M
Perk Hand Sanitizer Moisturizing GelALCOHOLWorklifebrands LLC18da87cf-6f59-41c6-a1da-cf32267f7de52024-12-20WarningsExact identifier
unii: 3K9958V90M
All Good Rose Geranium Hand SanitizerETHYL ALCOHOLElemental Herbs, Inc.f9b93df2-e28d-840e-e053-6294a90ae48a2024-12-20WarningsExact identifier
unii: 3K9958V90M
Alcare OR Foamed Antiseptic HandrubALCOHOLSC Johnson Professional USA, Inc.acc2f83f-6b9b-4552-8330-33e7b99397d82024-12-20WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Graepfruit Grove62% ETHYL ALCOHOLThe Honest Company540f8d6c-4472-2864-e054-00144ff88e882024-12-19WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Free and Clear62% ETHYL ALCOHOLThe Honest Company540d671e-5267-5b58-e054-00144ff88e882024-12-19WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Coastal Surf62% ETHYL ALCOHOLThe Honest Company53fd195e-641e-064e-e054-00144ff88e882024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Cinnamon Caramel SwirlALCOHOLBath & Body Works, Inc.29a359ef-03c2-c9da-e063-6294a90a16c02024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Mahogany AppleALCOHOLBath & Body Works, Inc.29a37481-91e7-de08-e063-6294a90a46a72024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Winter Candy AppleALCOHOLBath & Body Works, Inc.29a3aa8a-c698-a873-e063-6294a90a72c42024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Sun Washed CitrusALCOHOLBath & Body Works, Inc.29a3af85-35b5-80eb-e063-6294a90aadfd2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Cactus BlossomALCOHOLBath & Body Works, Inc.29a39319-8d25-e86a-e063-6394a90a8a8c2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Boardwalk Vanilla ConeALCOHOLBath & Body Works, Inc.29a3b5b3-c104-7754-e063-6294a90af8e72024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Sparkling WatermelonALCOHOLBath & Body Works, Inc.29a3af99-8186-9ec6-e063-6294a90ab8422024-12-19WarningsExact identifier
unii: 3K9958V90M
germstarONEETHYL ALCOHOLSoaptronic, LLCa6909a0f-de15-51e3-e053-2995a90ab34f2024-12-19WarningsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Vanilla Bean NoelALCOHOLBath & Body Works, Inc.29a4f4f7-8ac5-383c-e063-6394a90ad2d52024-12-19WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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