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 105 of 198 · 3,951 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Lotus Blossom ScentedALCOHOLFourstar Group USA, Inc.427fbc78-bbb7-48bf-85f7-74bf67a6319d2025-09-02WarningsExact identifier
unii: 3K9958V90M
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ProCure Hand SanitizerETHYL ALCOHOL 70%Twin Med LLC3d8422cf-0f30-e52a-e063-6394a90a957d2025-08-29WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLA-S Medication Solutionsab8654b8-a4d5-4869-88c2-6a6cc5c77fff2025-08-28Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dextrose and Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEBaxter Healthcare Companydcbf1907-1841-4afc-ab5d-a9893a2d72562025-08-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Good to Go Alcohol Wipes 15ctETHYL ALCOHOLNavajo Manufacturing Company Inc.3a263625-76e8-cdd0-e063-6294a90aa8802025-08-25WarningsExact identifier
unii: 3K9958V90M
terrasil Fast and Natural Wart RemovalGRAPHITE 10X, NATRUM MURIATICUM 3X, SYMPHYTUM OFFICINALE (COMFREY) 1X, THUJA OCCIDENTALIS 3XAidance Scientific, Inc.3d367c0f-5a28-eded-e063-6394a90ad2dc2025-08-25WarningsExact identifier
unii: 451W47IQ8X
Solar Flare Hand Sanitizer Brazilian Caramel DreamsALCOHOLScent Theory Products LLC3d0d4ccf-ea31-cab2-e063-6294a90a4c692025-08-23WarningsExact identifier
unii: 3K9958V90M
Solar Flare Hand Sanitizer Sunset SambaALCOHOLScent Theory Products LLC3d0d7d6b-33a0-5cd1-e063-6394a90ac8f62025-08-23WarningsExact identifier
unii: 3K9958V90M
Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco CremeALCOHOLScent Theory Products LLC3d0d7e73-8a83-9577-e063-6294a90aff6c2025-08-23WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Eucalyptus AloeALCOHOLScent Theory Products LLC3cf7e175-239d-e13b-e063-6294a90a79062025-08-22WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Sunrise GlowALCOHOLScent Theory Products LLC3cf7fce1-3112-0d66-e063-6294a90a98652025-08-22WarningsExact identifier
unii: 3K9958V90M
Cold Sore Treatment Extra StrengthECHINACEA ANGUSTIFOLIA WHOLE, SODIUM CHLORIDE, THUJA OCCIDENTALIS LEAFY TWIG, AND CALENDULA OFFICINALIS FLOWERING TOPForces of Nature0a5d32dc-c0e7-404e-85f2-6c3a338560ba2025-08-22WarningsExact identifier
unii: 451W47IQ8X
IncontinenceALOE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BENZOICUM ACIDUM, BRYONIA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM, IGNATIA, KALI PHOS., LYCOPODIUM, NAT. MUR., NITRICUM AC., PLANTAGO, PULSATILLA, RHUS AROMATICA , SABAL, SECALE, SEPIA, STAPHYSAG.,STRAMONIUM, THYROIDINUM, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.994cbc8e-a221-1548-e053-2995a90a1f7f2025-08-20WarningsExact identifier
unii: 451W47IQ8X
INSTANT HAND SANITIZER WIPESALCOHOL HAND SANITIZER WIPESDiamond Wipes International, Inc.e5d7bbcf-52b1-27d3-e053-2995a90a939f2025-08-19WarningsExact identifier
unii: 3K9958V90M
I-70 FoamingALCOHOL SANITIZERPeople's Janitorial Supply3cbabb95-c72f-6984-e063-6294a90adae02025-08-19WarningsExact identifier
unii: 3K9958V90M
Jacksons Cell Salts NAT MUR 6X 9NATRUM MURIATICUMZettl Health Inc.3cbe47fc-db38-e6e9-e063-6294a90a3f1c2025-08-19WarningsExact identifier
unii: 451W47IQ8X
Smart Care Hand Sanitizer 3pk - SOURBETALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9fe5a6-a729-4710-e063-6294a90a0da12025-08-18WarningsExact identifier
unii: 3K9958V90M
Premium Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.13d42582-df02-41d5-bada-1d67c61310152025-08-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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