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  5. NDC Package Code: 65174-021-10 Ruby-fill

NDC Package 65174-021-10 Ruby-fill

Rubidium Rb 82 Injection, Solution Intravenous - 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:
65174-021-10
Package Description:
1 INJECTION, SOLUTION in 1 CONTAINER
Product Code:
65174-021
Proprietary Name:
Ruby-fill
Non-Proprietary Name:
Rubidium Rb 82
Substance Name:
Rubidium Chloride Rb-82
Usage Information:
RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
11-Digit NDC Billing Format:
65174002110
Product Type:
Human Prescription Drug
Labeler Name:
Jubilant Draximage Inc., Dba Jubilant Radiopharma
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • RUBIDIUM CHLORIDE RB-82 100 mCi/1
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA202153
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-30-2016
    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 65174-021-10?

    The NDC Packaged Code 65174-021-10 is assigned to a package of 1 injection, solution in 1 container of Ruby-fill, a human prescription drug labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 65174-021 included in the NDC Directory?

    Yes, Ruby-fill with product code 65174-021 is active and included in the NDC Directory. The product was first marketed by Jubilant Draximage Inc., Dba Jubilant Radiopharma on September 30, 2016 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 65174-021-10?

    The 11-digit format is 65174002110. 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
    5-3-265174-021-105-4-265174-0021-10