Sotalol Hydrochloride Tablet
NDC Package 60505-0222-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Sotalol Hydrochloride tablets is 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. This formulation utilizes a tablet delivery system. Marketed by Apotex Corp., this product is identified by NDC 60505-0222 and is authorized under FDA application ANDA076214.

Identification & Billing

NDC Package Code
60505-0222-2
Package Description
1000 TABLET in 1 BOTTLE, PLASTIC
Product Code
60505-0222
11-Digit Billing Format
60505022202
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sotalol Hydrochloride
Non-Proprietary Name
Sotalol Hydrochloride
Substance Name
Sotalol Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SOTALOL HYDROCHLORIDE 80 mg/1
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Apotex Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA076214
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-09-2003
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (60505-0222). Click a package code to view its specific billing and regulatory data.

60505-0222-1
100 TABLET in 1 BOTTLE, PLASTIC

* 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 60505-0222-2 identifies a specific commercial package of 1000 tablet in 1 bottle, plastic of Sotalol Hydrochloride, a human prescription drug labeled by Apotex Corp.. This tablet is formulated for oral use and contains sotalol hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Apotex Corp. on September 09, 2003. The current certification is valid through December 31, 2026.

How is this Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505022202. 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 (5-4-1)
60505-0222-2
11-Digit CMS (5-4-2)
60505-0222-02

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