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 129 of 197 · 3,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERAALCOHOLAmerican Consumer Products Corpa8f00148-b8fa-6c4f-e053-2995a90ac5e22025-01-23WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Rejoice International Corp.052031f9-5206-c1bc-e063-6394a90ab0f22025-01-23WarningsExact identifier
unii: 3K9958V90M
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 1Q73Q2JULR
KeriCure Hand SanitizerALCOHOLKericure Inc.40d283ad-38a8-4ee6-bcba-56ccb99f7ee62025-01-22WarningsExact identifier
unii: 3K9958V90M
KeriCure Hand SanitizerALCOHOLKericure Inc.de516d2e-9c16-4bd2-b4c2-7e2f9fd264422025-01-22WarningsExact identifier
unii: 3K9958V90M
KeriCure Hand SanitizerALCOHOLKericure Inc.caa98aaa-1307-41df-a59d-258e1edd30812025-01-22WarningsExact identifier
unii: 3K9958V90M
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
unii: 3K9958V90M
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
unii: 3K9958V90M
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
unii: 3K9958V90M
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: 451W47IQ8X
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
Smart Care Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1b125c5d-7041-c71b-e063-6394a90add9b2025-01-17WarningsExact identifier
unii: 3K9958V90M
Berry Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f128054-4c57-8055-e063-6294a90adc4e2025-01-17WarningsExact identifier
unii: 3K9958V90M
SANI-CLAWSANI-CLAWHomeland Industrial Supply2be875a1-0e9d-2e2a-e063-6394a90a15202025-01-17WarningsExact identifier
unii: 3K9958V90M
MetoxALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Deseret Biologicals, Inc.deeae030-c266-44ab-8bc7-32c3292c72472025-01-17WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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