Betapace
NDC Package 50419-106-10

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.

Betapace is a medication used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. Marketed by Bayer Healthcare Pharmaceuticals Inc., this product is identified by NDC 50419-106 and is authorized under FDA application NDA019865.

Identification & Billing

NDC Package Code
50419-106-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
50419-106
11-Digit Billing Format
50419010610
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Betapace
Dosage Form
-
Usage Information
This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.

Regulatory & Marketing

Labeler Name
Bayer Healthcare Pharmaceuticals Inc.
FDA Application #
NDA019865
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-30-1992
End Marketing Date
11-10-2017
Listing Expiration
11-10-2017
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 50419-106-10 identifies a specific commercial package of 100 tablet in 1 bottle of Betapace, labeled by Bayer Healthcare Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. 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 Bayer Healthcare Pharmaceuticals Inc. on October 30, 1992. The current certification is valid through November 10, 2017.

What are the primary indications for this medication?

This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50419010610. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
50419-106-10
11-Digit CMS (5-4-2)
50419-0106-10

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