Mexiletine Hydrochloride Capsule
NDC Package 82012-028-04

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

Package Information

Mexiletine Hydrochloride capsules is uSP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. This formulation utilizes a capsule delivery system. Marketed by Senores Pharmaceuticals, Inc., this product is identified by NDC 82012-028 and is authorized under FDA application ANDA214089.

Identification & Billing

NDC Package Code
82012-028-04
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
82012-028
11-Digit Billing Format
82012002804
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mexiletine Hydrochloride
Non-Proprietary Name
Mexiletine Hydrochloride
Substance Name
Mexiletine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MEXILETINE HYDROCHLORIDE 200 mg/1
Pharmacologic Class
Antiarrhythmic - [EPC] (Established Pharmacologic Class)
Usage Information
Mexiletine hydrochloride capsules, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Regulatory & Marketing

Labeler Name
Senores Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214089
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2021
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 82012-028-04 identifies a specific commercial package of 100 capsule in 1 bottle of Mexiletine Hydrochloride, a human prescription drug labeled by Senores Pharmaceuticals, Inc.. This capsule is formulated for oral use and contains mexiletine 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 Senores Pharmaceuticals, Inc. on November 29, 2021. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82012002804. 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)
82012-028-04
11-Digit CMS (5-4-2)
82012-0028-04

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