Regadenoson Injection, Solution
NDC Package 76329-3321-0

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, solution delivery system. Marketed by International Medication Systems, Limited, this product is identified by NDC 76329-3321 and is authorized under FDA application ANDA214252.

Identification & Billing

NDC Package Code
76329-3321-0
Package Description
1 SYRINGE in 1 CARTON / 5 mL in 1 SYRINGE
Product Code
76329-3321
11-Digit Billing Format
76329332100
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 Anhydrous
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
REGADENOSON ANHYDROUS .08 mg/mL
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
International Medication Systems, Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA214252
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-20-2023
Listing Expiration
12-31-2026
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 76329-3321-0 identifies a specific commercial package of 1 syringe in 1 carton / 5 ml in 1 syringe of Regadenoson, a human prescription drug labeled by International Medication Systems, Limited. This injection, solution is formulated for intravenous use and contains regadenoson anhydrous 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 International Medication Systems, Limited on April 20, 2023. The current certification is valid through December 31, 2026.

How is this International Medication Systems, Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76329332100. 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 (5-4-1)
76329-3321-0
11-Digit CMS (5-4-2)
76329-3321-00

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