Betapace Af
NDC Package 70515-119-06

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 inactivated by the FDA.

Betapace Af is a medication used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. Marketed by Covis Pharma Us, Inc, this product is identified by NDC 70515-119 and is authorized under FDA application NDA021151.

Identification & Billing

NDC Package Code
70515-119-06
Package Description
60 TABLET in 1 BOTTLE
Product Code
70515-119
11-Digit Billing Format
70515011906
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betapace Af
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
Covis Pharma Us, Inc
FDA Application #
NDA021151
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2016
Listing Expiration
12-31-2024
Exclude Flag
I
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 70515-119-06 identifies a specific commercial package of 60 tablet in 1 bottle of Betapace Af, labeled by Covis Pharma Us, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 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 Covis Pharma Us, Inc on September 01, 2016. The current certification is valid through December 31, 2024.

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 Covis Pharma Us, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70515011906. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
70515-119-06
11-Digit CMS (5-4-2)
70515-0119-06

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