Sotalol Hydrochloride
NDC Package 10135-716-01

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.

Sotalol Hydrochloride is sotalol AF are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-716 and is authorized under FDA application ANDA207429.

Identification & Billing

NDC Package Code
10135-716-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
10135-716
11-Digit Billing Format
10135071601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sotalol Hydrochloride AF
Dosage Form
-
Usage Information
Sotalol AF are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Sotalol AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given Sotalol AF (see WARNINGS).In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see Clinical Studies).Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name Betapace® (sotalol hydrochloride). Sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (AF) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).

Regulatory & Marketing

Labeler Name
Marlex Pharmaceuticals Inc
FDA Application #
ANDA207429
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2020
Listing Expiration
12-31-2022
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 10135-716-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Sotalol Hydrochloride AF, labeled by Marlex Pharmaceuticals 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 Marlex Pharmaceuticals Inc on October 01, 2020. The current certification is valid through December 31, 2022.

How is this Marlex Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135071601. 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)
10135-716-01
11-Digit CMS (5-4-2)
10135-0716-01

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