Kit For The Preparation Of Technetium Tc 99m Sulfur Colloid Kit
NDC Package 65174-179-01

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 Technetium Tc 99m Sulfur Colloid (technetium tc 99m sulfur colloid kit) kits is technetium Tc 99m Sulfur Colloid Injection is indicated:In adults, to assist in the:Localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter.Evaluation of peritoneo-venous (LeVeen) shunt patency.In adults and pediatric patients, for imaging:Areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow.Studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents. This formulation utilizes a kit delivery system. Marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma, this product is identified by NDC 65174-179 and is authorized under FDA application ANDA213516.

Identification & Billing

NDC Package Code
65174-179-01
Package Description
1 KIT in 1 PACKAGE * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01)
Product Code
65174-179
11-Digit Billing Format
65174017901

Clinical Specifications

Proprietary Name
Kit For The Preparation Of Technetium Tc 99m Sulfur Colloid
Non-Proprietary Name
Technetium Tc 99m Sulfur Colloid Kit
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Technetium Tc 99m Sulfur Colloid Injection is indicated:In adults, to assist in the:Localization of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma when used with a hand-held gamma counter.Evaluation of peritoneo-venous (LeVeen) shunt patency.In adults and pediatric patients, for imaging:Areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow.Studies of esophageal transit and gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

Regulatory & Marketing

Labeler Name
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Product Type
Human Prescription Drug
FDA Application #
ANDA213516
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2023
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 65174-179-01 identifies a specific commercial package of 1 kit in 1 package * 3 ml in 1 vial (65174-046-01) * 3 ml in 1 vial (65174-047-01) * 10 ml in 1 vial (65174-131-01) of Kit For The Preparation Of Technetium Tc 99m Sulfur Colloid, a human prescription drug labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. 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 Jubilant Draximage Inc., Dba Jubilant Radiopharma on December 04, 2023. The current certification is valid through December 31, 2026.

How is this Jubilant Draximage Inc., Dba Jubilant Radiopharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65174017901. 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)
65174-179-01
11-Digit CMS (5-4-2)
65174-0179-01

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