Hepzato Kit

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDelcath Systems, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 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

Annotations

Orange Book

N201848

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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
}

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