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  5. NDC Package Code: 65174-200-05 Drax Exametazime

NDC Package 65174-200-05 Drax Exametazime

Kit For The Preparation Of Technetium Tc 99m Exametazime For Leukocyte Labeling Injection, - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
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
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
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.
11-Digit NDC Billing Format:
65174020005
Product Type:
Human Prescription Drug
Labeler Name:
Jubilant Draximage Inc., Dba Jubilant Radiopharma
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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • TECHNETIUM TC-99M EXAMETAZIME .5 mg/1
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA208870
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-17-2017
    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.

    Frequently Asked Questions

    What is NDC 65174-200-05?

    The NDC Packaged Code 65174-200-05 is assigned to a 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. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 65174-200 included in the NDC Directory?

    Yes, Drax Exametazime with product code 65174-200 is active and included in the NDC Directory. The product was first marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma on August 17, 2017 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 65174-200-05?

    The 11-digit format is 65174020005. 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
    5-3-265174-200-055-4-265174-0200-05