1. Home
  2. Labeler Index
  3. Apotex Corp.
  4. 60505-6116
  5. NDC Package Code: 60505-6116-0 Regadenoson

NDC Package 60505-6116-0 Regadenoson

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:
60505-6116-0
Package Description:
1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC
Product Code:
60505-6116
Proprietary Name:
Regadenoson
Non-Proprietary Name:
Regadenoson
Substance Name:
Regadenoson
Usage Information:
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
11-Digit NDC Billing Format:
60505611600
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Apotex Corp.
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):
  • REGADENOSON .08 mg/mL
    • Pharmacologic Class(es):
  • Adenosine Receptor Agonists - [MoA] (Mechanism of Action)
  • Pharmacologic Cardiac Stress Test Agent - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207604
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-10-2023
    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 60505-6116-0?

    The NDC Packaged Code 60505-6116-0 is assigned to a package of 1 syringe, plastic in 1 carton / 5 ml in 1 syringe, plastic of Regadenoson, a human prescription drug labeled by Apotex Corp.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 60505-6116 included in the NDC Directory?

    Yes, Regadenoson with product code 60505-6116 is active and included in the NDC Directory. The product was first marketed by Apotex Corp. on March 10, 2023 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 NDC billing unit for package 60505-6116-0?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 60505-6116-0?

    The 11-digit format is 60505611600. 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 5-4-1 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
    5-4-160505-6116-05-4-260505-6116-00