Hepzato Kit
NDC Package 75833-601-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Hepzato Kit (melphalan hydrochloride injection, powder, lyophilized, for solution) kits is 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. This formulation utilizes a kit delivery system. Marketed by Delcath Systems, Inc., this product is identified by NDC 75833-601 and is authorized under FDA application NDA201848.

Identification & Billing

NDC Package Code
75833-601-07
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
11-Digit Billing Format
75833060107
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hepzato Kit
Non-Proprietary Name
Melphalan Hydrochloride Injection, Powder, Lyophilized, For Solution
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intra-arterial - Administration within an artery or arteries.
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.

Regulatory & Marketing

Labeler Name
Delcath Systems, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA201848
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-04-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage
  • 75833 - Delcath Systems, Inc.
    • 75833-601 - Hepzato Kit
      • 75833-601-07 - 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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75833-601). Click a package code to view its specific billing and regulatory data.

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
75833-601-02
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
75833-601-08
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

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 75833-601-07 identifies a specific commercial 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.. This kit is formulated for intra-arterial use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Delcath Systems, Inc. on December 04, 2023. The current certification is valid through December 31, 2027.

How is this Delcath Systems, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75833060107. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
75833-601-07
11-Digit CMS (5-4-2)
75833-0601-07

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.