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  5. NDC Package Code: 75833-601-01 Hepzato Kit

NDC Package 75833-601-01 Hepzato Kit

Melphalan Hydrochloride Injection,Powder,Lyophilized,For Solution Kit Intra-arterial - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
75833-601-01
Package Description:
1 KIT in 1 BOX * 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
Product Code:
75833-601
Proprietary Name:
Hepzato Kit
Non-Proprietary Name:
Melphalan Hydrochloride Injection, Powder, Lyophilized, For Solution
Usage Information:
HEPZATO for injection, as a component of the HEPZATO KIT, is indicated as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
11-Digit NDC Billing Format:
75833060101
NDC to RxNorm Crosswalk:
  • RxCUI: 2671196 - HEPZATO 50 MG Injection
  • RxCUI: 2671196 - melphalan 50 MG Injection [Hepzato]
  • RxCUI: 2671196 - Hepzato 50 MG Injection
  • RxCUI: 311487 - melphalan 50 MG Injection
  • RxCUI: 311487 - melphalan (as melphalan hydrochloride) 50 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Delcath Systems, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Intra-arterial - Administration within an artery or arteries.
    • Sample Package:
    No
    FDA Application Number:
    NDA201848
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-04-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:
    • 75833 - Delcath Systems, Inc.
      • 75833-601 - Hepzato Kit
        • 75833-601-01 - 1 KIT in 1 BOX * 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

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    75833-601-021 KIT in 1 BOX * 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
    75833-601-071 KIT in 1 BOX * 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
    75833-601-081 KIT in 1 BOX * 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

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75833-601-01?

    The NDC Packaged Code 75833-601-01 is assigned to a package of 1 kit in 1 box * 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 of Hepzato Kit, a human prescription drug labeled by Delcath Systems, Inc.. The product's dosage form is kit and is administered via intra-arterial form.

    Is NDC 75833-601 included in the NDC Directory?

    Yes, Hepzato Kit with product code 75833-601 is active and included in the NDC Directory. The product was first marketed by Delcath Systems, Inc. on December 04, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 75833-601-01?

    The 11-digit format is 75833060101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-275833-601-015-4-275833-0601-01