Horizant Tablet, Extended Release
NDC Package 53451-0101-9

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

Horizant (gabapentin enacarbil) tablets is a medication used to treat moderate to severe restless legs syndrome. This formulation utilizes a tablet, extended release delivery system. Marketed by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), this product is identified by NDC 53451-0101 and is authorized under FDA application NDA022399.

Identification & Billing

NDC Package Code
53451-0101-9
Package Description
5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
53451-0101
11-Digit Billing Format
53451010109
RxNorm Crosswalk
  • RxCUI: 1101338 - gabapentin enacarbil 600 MG Extended Release Oral Tablet
  • RxCUI: 1101339 - Horizant 600 MG Extended Release Oral Tablet
  • RxCUI: 1101339 - gabapentin enacarbil 600 MG Extended Release Oral Tablet [Horizant]
  • RxCUI: 1482820 - gabapentin enacarbil 300 MG Extended Release Oral Tablet
  • RxCUI: 1482821 - Horizant 300 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Horizant
Non-Proprietary Name
Gabapentin Enacarbil
Substance Name
Gabapentin Enacarbil
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GABAPENTIN ENACARBIL 600 mg/1
Pharmacologic Class
Decreased Central Nervous System Disorganized Electrical Activity - [PE] (Physiologic Effect)
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
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Product Type
Human Prescription Drug
FDA Application #
NDA022399
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2013
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53451-0101). Click a package code to view its specific billing and regulatory data.

53451-0101-1
30 TABLET, EXTENDED RELEASE 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 53451-0101-9 identifies a specific commercial package of 5 tablet, extended release in 1 bottle, plastic of Horizant, a human prescription drug labeled by Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals). This tablet, extended release is formulated for oral use and contains gabapentin enacarbil 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 Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) on May 01, 2013. The current certification is valid through December 31, 2026.

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 Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53451010109. 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)
53451-0101-9
11-Digit CMS (5-4-2)
53451-0101-09

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