Technetium Tc 99m Sestamibi Injection, Powder, For Solution
NDC Package 45548-141-05

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

Package Information

Technetium Tc 99m Sestamibi injection is myocardial Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Jubilant Draximage (usa) Inc., this product is identified by NDC 45548-141 and is authorized under FDA application ANDA078806.

Identification & Billing

NDC Package Code
45548-141-05
Package Description
5 VIAL in 1 KIT / 10 mL in 1 VIAL
Product Code
45548-141
11-Digit Billing Format
45548014105

Clinical Specifications

Proprietary Name
Technetium Tc 99m Sestamibi
Non-Proprietary Name
Technetium Tc 99m Sestamibi
Substance Name
Technetium Tc-99m Sestamibi
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)
TECHNETIUM TC-99M SESTAMIBI 1 mg/mL
Pharmacologic Class
Usage Information
Myocardial Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agents labeling).It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.Kit for the preparation of Technetium Tc 99m Sestamibi Injection is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.

Regulatory & Marketing

Labeler Name
Jubilant Draximage (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078806
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2009
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45548-141). Click a package code to view its specific billing and regulatory data.

45548-141-10
10 VIAL in 1 KIT / 10 mL in 1 VIAL
45548-141-30
30 VIAL in 1 KIT / 10 mL in 1 VIAL

* 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 45548-141-05 identifies a specific commercial package of 5 vial in 1 kit / 10 ml in 1 vial of Technetium Tc 99m Sestamibi, a human prescription drug labeled by Jubilant Draximage (usa) Inc.. This injection, powder, for solution is formulated for intravenous use and contains technetium tc-99m sestamibi 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 (usa) Inc. on July 01, 2009. The current certification is valid through December 31, 2026.

How is this Jubilant Draximage (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45548014105. 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)
45548-141-05
11-Digit CMS (5-4-2)
45548-0141-05

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