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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.