FDA.reportPublic FDA data

NDC 75833-700 - 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
75833-700
Package NDCs from labels
75833-700-01
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
75833-700HEPZATO 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 6 of 201 · 4,015 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
unii: 3K9958V90M
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER rose petalALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594befe7-1701-02a2-e063-6294a90a236c2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER SWEETR GUAVA FRESH COCONUTALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594c32b7-6905-4ab9-e063-6294a90a1db32026-08-18WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLLidl US, LLCc7746330-2943-491a-bafc-0c8dd4fa40e22026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLNice-Pak Products, LLCdc071394-60de-4b13-a962-9a643b01b1062026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
HDXETHYL ALCOHOLApollo Health and Beauty Caredf0063b2-2e30-428e-b5cf-24e566c388c22026-08-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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