Medicine
Hepzato Kit kit
Hepzato Kit kit is a prescription medicine containing Melphalan hydrochloride injection for intra-arterial use, marketed by Delcath Systems, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
HEPZATO for injection and its associated diluents including 0.9% sodium…
Key facts
- Active ingredient (INN)
- Melphalan hydrochloride injection
- Brand
- Hepzato Kit
- Dosage form
- Kit
- Route
- Intra-arterial
- Packs
- 1 kit
- Marketing authorisation holder
- Delcath Systems
- Manufacturer
- Delcath Systems
- Origin register
- US FDA, United States
- Storage
- HEPZATO for injection and its associated diluents including 0.9% sodium chloride must be stored at controlled room temperature 20°C to 25°C (68°F to 77°F). Temperature excursions are permitted between 15°C- 30°C (59°F-86°F). The Hepatic Delivery System components may be stored at room temperature.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 December 2023
- Identifiers
- RxCUI 311487, 2671196DailyMed set ID 4f83c8f7-4cc0-4219-88d5-7cfddce91198NDC 75833-601Application NDA201848
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 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 | 75833-601-01 | Delcath Systems | 4 December 2023 |
| 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 | 75833-601-02 | Delcath Systems | 4 December 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Melphalan hydrochloride injection is a prescription medicine. It is available as kits for intra-arterial use. MedsAcross supplies Melphalan hydrochloride injection for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Melphalan hydrochloride injectionFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Hepzato Kit prescribing information (Delcath Systems) · U.S. National Library of Medicine, DailyMed
Need Hepzato Kit kit for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.