Technetium Tc 99m Sestamibi Injection
NDC Package 69945-092-40

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: Technetium Tc99m Sestamibi 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 delivery system. Marketed by Curium Us Llc, this product is identified by NDC 69945-092 and is authorized under FDA application ANDA078098.

Identification & Billing

NDC Package Code
69945-092-40
Package Description
30 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code
69945-092
11-Digit Billing Format
69945009240
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Technetium Tc 99m Sestamibi
Non-Proprietary Name
Technetium Tc 99m Sestamibi
Substance Name
Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL
Usage Information
            Myocardial Imaging: Technetium Tc99m Sestamibi 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 Tc99m 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 agent’s 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: Technetium Tc99m Sestamibi 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.       Technetium Tc99m Sestamibi 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
Curium Us Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078098
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2011
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 (69945-092). Click a package code to view its specific billing and regulatory data.

69945-092-20
5 VIAL in 1 CELLO PACK / 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 69945-092-40 identifies a specific commercial package of 30 vial in 1 carton / 10 ml in 1 vial of Technetium Tc 99m Sestamibi, a human prescription drug labeled by Curium Us Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection is formulated for intravenous use and contains tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate 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 Curium Us Llc on October 31, 2011. The current certification is valid through December 31, 2026.

How is this Curium Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69945009240. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
69945-092-40
11-Digit CMS (5-4-2)
69945-0092-40

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