Illuccix Kit
NDC Package 74725-100-64

11-digit billing NDC: 74725010064 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Illuccix (kit for the preparation of gallium ga 68 gozetotide injection) kits is iLLUCCIX®, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:with suspected metastasis who are candidates for initial definitive therapy.with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This formulation utilizes a kit delivery system. Marketed by Telix Pharmaceuticals (us) Inc., this product is identified by NDC 74725-100 and is authorized under FDA application NDA214032.

Identification & Billing

NDC Package Code
74725-100-64
Package Description
1 KIT in 1 CARTON * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)
Product Code
74725-100
11-Digit Billing Format
74725010064
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Illuccix
Non-Proprietary Name
Kit For The Preparation Of Gallium Ga 68 Gozetotide Injection
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
Usage Information
ILLUCCIX®, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:with suspected metastasis who are candidates for initial definitive therapy.with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Regulatory & Marketing

Labeler Name
Telix Pharmaceuticals (us) Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214032
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-17-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 (74725-100). Click a package code to view its specific billing and regulatory data.

74725-100-25
1 KIT in 1 CARTON * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25)

* 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 74725-100-64 identifies a specific commercial package of 1 kit in 1 carton * 2.5 ml in 1 vial, multi-dose (74725-102-25) * 6.4 ml in 1 vial, multi-dose (74725-103-64) * 1 injection, powder, lyophilized, for solution in 1 vial, multi-dose (74725-101-25) of Illuccix, a human prescription drug labeled by Telix Pharmaceuticals (us) Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This kit is formulated for intravenous 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 Telix Pharmaceuticals (us) Inc. on December 17, 2021. The current certification is valid through December 31, 2027.

How is this Telix Pharmaceuticals (us) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74725010064. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
74725-100-64
11-Digit CMS (5-4-2)
74725-0100-64

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