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 123 of 197 · 3,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
unii: 3K9958V90M
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
unii: 3K9958V90M
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: 3K9958V90M
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
COCONUT SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.fe347d07-496a-468a-bc38-d47b0f22c4332025-02-25WarningsExact identifier
unii: 3K9958V90M
CITRUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.64b2fef3-8d06-471d-b950-d4c355119dfa2025-02-25WarningsExact identifier
unii: 3K9958V90M
LAVENDER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.0e5e21c3-9ee5-44be-988a-f82ac95230592025-02-25WarningsExact identifier
unii: 3K9958V90M
ALOE SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.aacde143-ecf1-47ce-ada3-8e74551d06592025-02-25WarningsExact identifier
unii: 3K9958V90M
EUCALYPTUS SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.068ed8c0-1fff-42dd-a217-684201c160232025-02-25WarningsExact identifier
unii: 3K9958V90M
SHEA BUTTER SCENTED HAND SANITIZERALCOHOLFOURSTAR GROUP USA, INC.669451fa-7557-4ef5-a668-fe4fea1f0c9b2025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Crayola HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.def18e33-0a6b-40f8-a771-fcae1e6a1c822025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care SPIDER-MAN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.db147cc8-6323-428b-b506-8ab7211cb3e62025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Hot Wheels HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.046d534c-1bde-439c-9a90-8713aaada1a12025-02-25WarningsExact identifier
unii: 3K9958V90M
Smart Care Barbie HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e9acb658-946d-405c-ad41-8b52542998bd2025-02-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
unii: 3K9958V90M
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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