Regadenoson
NDC Package 0407-5034-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Regadenoson is a . Marketed by Ge Healthcare Inc., this product is identified by NDC 0407-5034 and is authorized under FDA application ANDA215955.

Identification & Billing

NDC Package Code
0407-5034-05
Package Description
10 SYRINGE, PLASTIC in 1 BOX / 5 mL in 1 SYRINGE, PLASTIC
Product Code
0407-5034
11-Digit Billing Format
00407503405

Clinical Specifications

Proprietary Name
Regadenoson
Dosage Form
-

Regulatory & Marketing

Labeler Name
Ge Healthcare Inc.
FDA Application #
ANDA215955
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-28-2025
End Marketing Date
02-16-2026
Listing Expiration
02-16-2026
Exclude Flag
D
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 0407-5034-05 identifies a specific commercial package of 10 syringe, plastic in 1 box / 5 ml in 1 syringe, plastic of Regadenoson, labeled by Ge Healthcare Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Ge Healthcare Inc. on March 28, 2025. The current certification is valid through February 16, 2026.

How is this Ge Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00407503405. 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 (4-4-2)
0407-5034-05
11-Digit CMS (5-4-2)
00407-5034-05

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