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  5. NDC Package Code: 60505-0082-1 Sotalol Hydrochloride

NDC Package 60505-0082-1 Sotalol Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
60505-0082-1
Package Description:
1000 TABLET in 1 BOTTLE
Product Code:
60505-0082
Proprietary Name:
Sotalol Hydrochloride
Non-Proprietary Name:
Sotalol Hydrochloride
Substance Name:
Sotalol Hydrochloride
Usage Information:
Sotalol hydrochloride tablets, USP (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 hydrochloride tablets, USP (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 hydrochloride tablets, USP (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 Betapace AF (sotalol hydrochloride tablets, USP (AF) because of significant differences in labeling (i.e. patient package insert, dosing administration and safety information).
11-Digit NDC Billing Format:
60505008201
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Apotex Corp.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SOTALOL HYDROCHLORIDE 240 mg/1
    • Pharmacologic Class(es):
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • Antiarrhythmic - [EPC] (Established Pharmacologic Class)
  • Cardiac Rhythm Alteration - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076140
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-01-2003
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    60505-0082-0100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 60505-0082-1?

    The NDC Packaged Code 60505-0082-1 is assigned to a package of 1000 tablet in 1 bottle of Sotalol Hydrochloride, a human prescription drug labeled by Apotex Corp.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 60505-0082 included in the NDC Directory?

    Yes, Sotalol Hydrochloride with product code 60505-0082 is active and included in the NDC Directory. The product was first marketed by Apotex Corp. on February 01, 2003 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 60505-0082-1?

    The 11-digit format is 60505008201. 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 5-4-1 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
    5-4-160505-0082-15-4-260505-0082-01