Drax Exametazime Injection, Powder, Lyophilized, For Solution
NDC Package 65174-200-05

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

Package Information

Drax Exametazime (kit for the preparation of technetium tc 99m exametazime for leukocyte labeling) injection is drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma, this product is identified by NDC 65174-200 and is authorized under FDA application NDA208870.

Identification & Billing

NDC Package Code
65174-200-05
Package Description
5 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)
Product Code
65174-200
11-Digit Billing Format
65174020005
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA

Clinical Specifications

Proprietary Name
Drax Exametazime
Non-Proprietary Name
Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling
Substance Name
Technetium Tc-99m Exametazime
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TECHNETIUM TC-99M EXAMETAZIME .5 mg/1
Pharmacologic Class
Usage Information
Drax Exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.

Regulatory & Marketing

Labeler Name
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Product Type
Human Prescription Drug
FDA Application #
NDA208870
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-17-2017
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 65174-200-05 identifies a specific commercial package of 5 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial (65174-200-01) of Drax Exametazime, 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 5 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains technetium tc-99m exametazime 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 August 17, 2017. 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: 65174020005. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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)
65174-200-05
11-Digit CMS (5-4-2)
65174-0200-05

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