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  5. NDC Package Code: 45548-141-05 Technetium Tc 99m Sestamibi

NDC Package 45548-141-05 Technetium Tc 99m Sestamibi

Injection, Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
45548-141-05
Package Description:
5 VIAL in 1 KIT / 10 mL in 1 VIAL
Product Code:
45548-141
Proprietary Name:
Technetium Tc 99m Sestamibi
Non-Proprietary Name:
Technetium Tc 99m Sestamibi
Substance Name:
Technetium Tc-99m Sestamibi
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.
11-Digit NDC Billing Format:
45548014105
Product Type:
Human Prescription Drug
Labeler Name:
Jubilant Draximage (usa) Inc.
Dosage Form:
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TECHNETIUM TC-99M SESTAMIBI 1 mg/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078806
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-01-2009
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    45548-141-1010 VIAL in 1 KIT / 10 mL in 1 VIAL
    45548-141-3030 VIAL in 1 KIT / 10 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 45548-141-05?

    The NDC Packaged Code 45548-141-05 is assigned to a 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.. The product's dosage form is injection, powder, for solution and is administered via intravenous form.

    Is NDC 45548-141 included in the NDC Directory?

    Yes, Technetium Tc 99m Sestamibi with product code 45548-141 is active and included in the NDC Directory. The product was first marketed by Jubilant Draximage (usa) Inc. on July 01, 2009 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 45548-141-05?

    The 11-digit format is 45548014105. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-245548-141-055-4-245548-0141-05