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 11 of 201 · 4,015 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sherk Hand Sanitizer Blue Blueberry And Waffle SyrupALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598f14fc-c34c-0b4e-e063-6394a90acf0c2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Lavender Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0a6abf-fbab-3db5-e063-6294a90a6a302026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Watermelon Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ac249-7b91-a83f-e063-6294a90a93742026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY VANILLA SUGAR COOKIES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0b1e6c-850c-05e0-e063-6294a90afa462026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY SUGAR RUSH HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ba647-ee25-952a-e063-6294a90ad4712026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify twin cherry hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a148ff2-42bd-7288-e063-6394a90aae642026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer StrawberryALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a170880-4867-9aac-e063-6394a90a3e4f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify strawberry and cream hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a2b3f7b-5981-ed93-e063-6294a90a7b192026-08-01WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Green Certified FoamALCOHOLGOJO Industries, LLC57d91ee6-a166-dc13-e063-6294a90a2f5e2026-07-31WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer GelALCOHOLGOJO Industries, LLC57ecffc4-2c30-84ad-e063-6394a90a68e72026-07-31WarningsExact identifier
unii: 3K9958V90M
Zoono Ultra Hand SanitizerALCOHOLZoono Holdings USA, LLC3dbb255c-1256-66a7-e054-00144ff8d46c2026-07-31WarningsExact identifier
unii: 3K9958V90M
Dehydrated AlcoholALCOHOLAvenacy, LLC90e92d21-9821-4132-b17d-d98d523f12e82026-07-31Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
WhiskCare 373ALCOHOLWhisk Products, Inc.cce95a6a-1188-4c69-8f20-4a1670c4c09b2026-07-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio BruleeALCOHOLShenzhen Lantern Scicence Co.,Ltd.57bd148e-f9eb-dfb6-e063-6394a90a1e122026-07-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber MelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.57cb54f7-07be-524f-e063-6294a90a2c942026-07-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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