Sotalol Hydrochloride Tablet
NDC Package 72789-137-01

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

Package Information

Sotalol Hydrochloride tablets is sotalol hydrochloride is contraindicated in patients with:Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is presentCongenital or acquired long QT syndromesCardiogenic shock or decompensated heart failureSerum potassium <4 mEq/LBronchial asthma or related bronchospastic conditionsHypersensitivity to sotalolFor the treatment of AFIB/AFL, sotalol hydrochloride is also contraindicated in patients with:Baseline QT interval >450 msCreatinine clearance < 40 mL/min. This formulation utilizes a tablet delivery system. Marketed by Pd-rx Pharmaceuticals, Inc., this product is identified by NDC 72789-137 and is authorized under FDA application ANDA075563.

Identification & Billing

NDC Package Code
72789-137-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
72789-137
11-Digit Billing Format
72789013701
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 is contraindicated in patients with:Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is presentCongenital or acquired long QT syndromesCardiogenic shock or decompensated heart failureSerum potassium <4 mEq/LBronchial asthma or related bronchospastic conditionsHypersensitivity to sotalolFor the treatment of AFIB/AFL, sotalol hydrochloride is also contraindicated in patients with:Baseline QT interval >450 msCreatinine clearance < 40 mL/min

Regulatory & Marketing

Labeler Name
Pd-rx Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075563
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72789-137-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Sotalol Hydrochloride, a human prescription drug labeled by Pd-rx Pharmaceuticals, Inc.. 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 Pd-rx Pharmaceuticals, Inc. on July 24, 2020. The current certification is valid through December 31, 2026.

How is this Pd-rx Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72789013701. 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)
72789-137-01
11-Digit CMS (5-4-2)
72789-0137-01

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