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 | Type |
|---|---|---|---|
| melphalan hydrochloride injection, powder, lyophilized, for solution | Delcath Systems, Inc. | 2026-06-09 | HUMAN PRESCRIPTION DRUG LABEL |
| melphalan hydrochloride injection, powder, lyophilized, for solution | Delcath Systems, Inc. | 2025-09-04 | Risk Evaluation & Mitigation Strategies |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75833-444-01 | Hepzato Kit | 2 in 1 BOX | INJECTION, SOLUTION | 0.9 mg in 100mL | 7 | |
| 75833-444-01 | Hepzato Kit | 250 mL in 1 BAG | INJECTION, SOLUTION | 500 mL | 0.9 mg in 100mL | 7 |
DailyMed Dashboard NDC Coverage#
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.
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Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.