Technetium Tc 99m Medronate Injection, Powder, For Solution
NDC Package 65174-660-30

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

Package Information

Technetium Tc 99m Medronate injection is mDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma, this product is identified by NDC 65174-660 and is authorized under FDA application NDA018035.

Identification & Billing

NDC Package Code
65174-660-30
Package Description
30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON
Product Code
65174-660
11-Digit Billing Format
65174066030
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Technetium Tc 99m Medronate
Non-Proprietary Name
Technetium Tc 99m Medronate
Substance Name
Medronic Acid
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MEDRONIC ACID 25 mg/1
Usage Information
MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate) may be used as a bone imaging agent to delineate areas of altered osteogenesis.

Regulatory & Marketing

Labeler Name
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Product Type
Human Prescription Drug
FDA Application #
NDA018035
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-27-2004
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 65174-660-30 identifies a specific commercial package of 30 injection, powder, for solution in 1 carton of Technetium Tc 99m Medronate, a human prescription drug labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This injection, powder, for solution is formulated for intravenous use and contains medronic acid 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 February 27, 2004. 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: 65174066030. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
65174-660-30
11-Digit CMS (5-4-2)
65174-0660-30

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