Horizant
NDC Package 53451-0102-1

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.

Horizant is a medication used to treat moderate to severe restless legs syndrome. Marketed by Xenoport Inc., this product is identified by NDC 53451-0102 and is authorized under FDA application NDA022399.

Identification & Billing

NDC Package Code
53451-0102-1
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
53451-0102
11-Digit Billing Format
53451010201

Clinical Specifications

Proprietary Name
Horizant
Dosage Form
-
Usage Information
This medication is used to treat moderate to severe restless legs syndrome. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection). This condition is called postherpetic neuralgia. Gabapentin enacarbil is changed by your body to gabapentin. Gabapentin belongs to a class of drugs known as anti-seizure or anticonvulsant drugs.

Regulatory & Marketing

Labeler Name
Xenoport Inc.
FDA Application #
NDA022399
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2013
End Marketing Date
10-17-2013
Listing Expiration
10-17-2013
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 53451-0102-1 identifies a specific commercial package of 30 tablet, extended release in 1 bottle, plastic of Horizant, labeled by Xenoport Inc.. 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 Xenoport Inc. on May 01, 2013. The current certification is valid through October 17, 2013.

What are the primary indications for this medication?

This medication is used to treat moderate to severe restless legs syndrome. It is also used to relieve nerve pain following shingles (a painful rash due to herpes zoster infection). This condition is called postherpetic neuralgia. Gabapentin enacarbil is changed by your body to gabapentin. Gabapentin belongs to a class of drugs known as anti-seizure or anticonvulsant drugs.

How is this Xenoport Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53451010201. 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)
53451-0102-1
11-Digit CMS (5-4-2)
53451-0102-01

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