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  5. NDC Package Code: 10135-716-01 Sotalol Hydrochloride AF

NDC Package 10135-716-01 Sotalol Hydrochloride AF

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
10135-716-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
10135-716
Proprietary Name:
Sotalol Hydrochloride AF
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).
11-Digit NDC Billing Format:
10135071601
NDC to RxNorm Crosswalk:
  • RxCUI: 1922720 - sotalol HCl AF 120 MG Oral Tablet
  • RxCUI: 1922720 - Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet
  • RxCUI: 1922720 - sotalol hydrochloride AF 120 MG Oral Tablet
  • RxCUI: 1922763 - sotalol HCl AF 160 MG Oral Tablet
  • RxCUI: 1922763 - Atrial Fibrillation sotalol hydrochloride 160 MG Oral Tablet
    • Labeler Name:
    Marlex Pharmaceuticals Inc
    Sample Package:
    No
    Start Marketing Date:
    10-01-2020
    Listing Expiration Date:
    12-31-2022
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 10135-716-01?

    The NDC Packaged Code 10135-716-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Sotalol Hydrochloride AF, labeled by Marlex Pharmaceuticals Inc. The product's dosage form is and is administered via form.

    Is NDC 10135-716 included in the NDC Directory?

    No, Sotalol Hydrochloride AF with product code 10135-716 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Marlex Pharmaceuticals Inc on October 01, 2020 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 10135-716-01?

    The 11-digit format is 10135071601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-210135-716-015-4-210135-0716-01