Sotalol Tablet
NDC Package 76385-116-01

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 (sotalol hydrochloride) tablets is a medication used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. This formulation utilizes a tablet delivery system. Marketed by Unichem Pharmaceuticals (usa), Inc., this product is identified by NDC 76385-116 and is authorized under FDA application ANDA207428.

Identification & Billing

NDC Package Code
76385-116-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
76385-116
11-Digit Billing Format
76385011601
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sotalol
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 160 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.

Regulatory & Marketing

Labeler Name
Unichem Pharmaceuticals (usa), Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207428
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-06-2017
Listing Expiration
12-31-2027
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 (76385-116). Click a package code to view its specific billing and regulatory data.

76385-116-50
500 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 76385-116-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Sotalol, a human prescription drug labeled by Unichem Pharmaceuticals (usa), 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 Unichem Pharmaceuticals (usa), Inc. on December 06, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.

How is this Unichem Pharmaceuticals (usa), Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76385011601. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
76385-116-01
11-Digit CMS (5-4-2)
76385-0116-01

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