Sotalol Hydrochloride Tablet
NDC Package 0093-1063-01

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 are contraindicated in patients with:•Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present•Congenital or acquired long QT syndromes•Cardiogenic shock or decompensated heart failure•Serum potassium <4 mEq/L•Bronchial asthma or related bronchospastic conditions•Hypersensitivity to sotalolFor the treatment of AFIB/AFL, sotalol hydrochloride tablets are also contraindicated in patients with:•Baseline QT interval >450 ms•Creatinine clearance <40 mL/min. This formulation utilizes a tablet delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-1063 and is authorized under FDA application ANDA075429.

Identification & Billing

NDC Package Code
0093-1063-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
0093-1063
11-Digit Billing Format
00093106301
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 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 240 mg/1
Pharmacologic Class
Usage Information
Sotalol hydrochloride tablets are contraindicated in patients with:•Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present•Congenital or acquired long QT syndromes•Cardiogenic shock or decompensated heart failure•Serum potassium <4 mEq/L•Bronchial asthma or related bronchospastic conditions•Hypersensitivity to sotalolFor the treatment of AFIB/AFL, sotalol hydrochloride tablets are also contraindicated in patients with:•Baseline QT interval >450 ms•Creatinine clearance <40 mL/min

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075429
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-05-2000
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 0093-1063-01 identifies a specific commercial package of 100 tablet in 1 bottle of Sotalol Hydrochloride, a human prescription drug labeled by Teva 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 Teva Pharmaceuticals Usa, Inc. on May 05, 2000. The current certification is valid through December 31, 2026.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093106301. 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 (4-4-2)
0093-1063-01
11-Digit CMS (5-4-2)
00093-1063-01

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