The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Hepzato Kit
melphalan hydrochloride injection, powder, lyophilized, for solution · Kit · Intra-Arterial · Delcath Systems, Inc.
NDC 75833-0601-01 · 1 KIT in 1 BOX * 5 VIAL, SINGLE-USE in 1 BOX / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX / 10 mL in 1 VIAL, SINGLE-USE · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$187,500.00
Reported to Texas DSHS · 2026 annual filing · Delcath Systems, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 1 MG
$801.479
HCPCS J9248 · Jul 1, 2026 quarter · typically ASP + 6%
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Is this a "specialty" drug?
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program · Hepzato
Regulatory
- Application
- NDA201848
- TE code
- —
- Approval date
- Aug 14, 2023
- Patents / exclusivity
- 10 patents, 2 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| exclusivity | ODE-438 | Aug 14, 2030 |
| exclusivity | NP | Aug 14, 2026 |
| patent | 9707331 | Sep 17, 2034 |
| patent | 9314561 | Feb 7, 2034 |
| patent | 10195334 | Jan 16, 2033 |
| patent | 11833286 | Dec 30, 2032 |
| patent | 11083831 | Dec 30, 2032 |
| patent | 11241522 | Nov 7, 2032 |
| patent | 10369264 | Nov 7, 2032 |
| patent | 10569004 | Nov 7, 2032 |
| patent | 10098997 | Nov 7, 2032 |
| patent | 11633528 | Nov 7, 2032 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of melphalan hydrochloride injection, powder, lyophilized, for solution (Kit)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Delcath Systems, Inc. | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Hepzato Kit — NDC 75833-0601-01," retrieved September 3, 2026, https://drugdashboards.com/drug/75833060101.
Free to cite with attribution — see how the data is put together.