Regadenoson Injection
NDC Package 67457-994-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. This formulation utilizes a injection delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-994 and is authorized under FDA application ANDA213856.

Identification & Billing

NDC Package Code
67457-994-05
Package Description
1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE
Product Code
67457-994
11-Digit Billing Format
67457099405
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Regadenoson
Non-Proprietary Name
Regadenoson
Substance Name
Regadenoson
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)
REGADENOSON .4 mg/5mL
Pharmacologic Class
Usage Information
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213856
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2023
End Marketing Date
06-30-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67457-994-05 identifies a specific commercial package of 1 syringe in 1 carton / 5 ml in 1 syringe of Regadenoson, a human prescription drug labeled by Mylan Institutional Llc. This injection is formulated for intravenous use and contains regadenoson 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 Mylan Institutional Llc on September 21, 2023.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457099405. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
67457-994-05
11-Digit CMS (5-4-2)
67457-0994-05

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