Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) Kit
NDC Package 65857-425-05

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

Package Information

Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept) (tilmanocept) kits is lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:•Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.•Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. This formulation utilizes a kit delivery system. Marketed by Cardinal Health 414, Llc, this product is identified by NDC 65857-425 and is authorized under FDA application NDA202207.

Identification & Billing

NDC Package Code
65857-425-05
Package Description
1 KIT in 1 CARTON / 1 KIT in 1 KIT * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65857-400-01)
Product Code
65857-425
11-Digit Billing Format
65857042505
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept)
Non-Proprietary Name
Tilmanocept
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:•Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.•Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Regulatory & Marketing

Labeler Name
Cardinal Health 414, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA202207
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-20-2017
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65857-425-05 identifies a specific commercial package of 1 kit in 1 carton / 1 kit in 1 kit * 1 injection, powder, lyophilized, for solution in 1 vial (65857-400-01) of Kit For The Preparation Of Lymphoseek (technetium Tc 99m Tilmanocept), a human prescription drug labeled by Cardinal Health 414, Llc. This kit is formulated for 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 Cardinal Health 414, Llc on September 20, 2017. The current certification is valid through December 31, 2026.

How is this Cardinal Health 414, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65857042505. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
65857-425-05
11-Digit CMS (5-4-2)
65857-0425-05

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