Mexiletine Hydrochloride
NDC Package 63629-9290-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Mexiletine Hydrochloride is 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. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-9290 and is authorized under FDA application ANDA074450.

Identification & Billing

NDC Package Code
63629-9290-1
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
63629-9290
11-Digit Billing Format
63629929001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Mexiletine Hydrochloride
Dosage Form
-
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
Bryant Ranch Prepack
FDA Application #
ANDA074450
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-22-2020
End Marketing Date
04-24-2026
Listing Expiration
04-24-2026
Exclude Flag
D
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 63629-9290-1 identifies a specific commercial package of 100 capsule in 1 bottle of Mexiletine Hydrochloride, labeled by Bryant Ranch Prepack. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bryant Ranch Prepack on June 22, 2020. The current certification is valid through April 24, 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: 63629929001. 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 (5-4-1)
63629-9290-1
11-Digit CMS (5-4-2)
63629-9290-01

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