Sotalol Hydrochloride Tablet
NDC Package 71335-1125-2

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 sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). This formulation utilizes a tablet delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-1125 and is authorized under FDA application ANDA076140.

Identification & Billing

NDC Package Code
71335-1125-2
Package Description
30 TABLET in 1 BOTTLE
Product Code
71335-1125
11-Digit Billing Format
71335112502
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 120 mg/1
Pharmacologic Class
Usage Information
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use:Sotalol hydrochloride/Sotalol hydrochloride AF tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of sotalol hydrochloride/ sotalol hydrochloride AF tablets, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions [see Warnings and Precautions (5.2)].

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA076140
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2003
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 (71335-1125). Click a package code to view its specific billing and regulatory data.

71335-1125-1
60 TABLET in 1 BOTTLE
71335-1125-3
90 TABLET in 1 BOTTLE

* 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 71335-1125-2 identifies a specific commercial package of 30 tablet in 1 bottle of Sotalol Hydrochloride, a human prescription drug labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on February 01, 2003. The current certification is valid through December 31, 2026.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335112502. 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)
71335-1125-2
11-Digit CMS (5-4-2)
71335-1125-02

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