United States· US:75833-601_cc805aea-2daa-4855-8c1d-7233738b6e6f

Hepzato Kit

A medicinal product containing melphalan hydrochloride injection, powder, lyophilized, for solution, registered in United States by Delcath Systems, Inc..

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on June 3, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about melphalan hydrochloride injection, powder, lyophilized, for solutionAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: melphalan hydrochloride injection, powder, lyophilized, for solution
Manufacturer: Delcath Systems, Inc.
Country: United States (US)
ATC code: —
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: June 3, 2026

Packs & prices · 4

ndc11
7583360101
1 KIT in 1 BOX (75833-601-01) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
ndc11
7583360102
1 KIT in 1 BOX (75833-601-02) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
ndc11
7583360107
1 KIT in 1 BOX (75833-601-07) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
ndc11
7583360108
1 KIT in 1 BOX (75833-601-08) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE

Regulatory notes

Orange Book

N201848

DailyMed SPL labels

1 version tracked

Same medicine, other countries

Melphalan hydrochloride injection, powder, lyophilized, for solution in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All melphalan hydrochloride injection, powder, lyophilized, for solution products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

Austria · Alkeran, Melphalan Hikma
Belgium · Alkeran, Melfalan Tillomed
Cyprus · Melfalan Tillomed
Czechia · Alkeran, Melphalan Zentiva
Germany · Alkeran, Melphalan
Denmark · Alkeran, Melphalan Macure
Estonia · Alkeran
Spain · Alkeran, Melfalán Aspen
Finland · Alkeran, Melphalan Macure
France · Alkeran, Melphalan Hikma
United Kingdom (Northern Ireland) · Melphalan, Melphalan Accord-Uk
Greece · Demephan, Melphalan Tillomed
Croatia · Melfalan Pliva, Melfalan Tillomed
Hungary · Melphalan Teva, Melphalan Zentiva
Ireland · Alkeran, Melphalan Tillomed
Iceland · Alkeran, Phelinun
Italy · Alkeran, Melfalan Hikma
Liechtenstein · Phelinun
Lithuania · Alkeran, Melphalan Zentiva
Luxembourg · Alkeran, Melphalan Aqvida
Latvia · Alkeran, Melphalan Tillomed
Netherlands · Alkeran, Melfalan Amarox
Norway · Alkeran, Melphalan Macure
Poland · Alkeran, Melphalan Zentiva
Portugal · Alkeran, Melfalano Eugia
Romania · Alkeran, Melfalan Teva
Sweden · Alkeran, Melfalan Sun
Slovenia · Alkeran, Melfalan Teva
Slovakia · Alkeran, Melphalan Zentiva

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/f9fdb1de-9bd4-4848-b364-b49cac77d553
GET /v1/drugs/f9fdb1de-9bd4-4848-b364-b49cac77d553?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "INTRA-ARTERIAL",
  "spl_meta": {
    "4f83c8f7-4cc0-4219-88d5-7cfddce91198": {
      "match": "brand_token",
      "title": "HEPZATO KIT (MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION) KIT [DELCATH SYSTEMS, INC.]",
      "spl_version": "7",
      "published_date": "2025-05-22"
    }
  },
  "productid": "75833-601_cc805aea-2daa-4855-8c1d-7233738b6e6f",
  "productndc": "75833-601",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201848",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 14, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Hepzato Kit",
  "active_ingred_unit": null,
  "application_number": "NDA201848",
  "marketing_category": "NDA",
  "nonproprietary_name": "melphalan hydrochloride injection, powder, lyophilized, for solution",
  "start_marketing_date": "20231204",
  "active_numerator_strength": null
}

API reference MCP server Plans

See everything about melphalan hydrochloride injection, powder, lyophilized, for solution.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

Try it free Open in the console