Gabapentin Enacarbil Powder
NDC Package 66039-945-04

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Gabapentin Enacarbil powders is a medication used to treat moderate to severe restless legs syndrome. This formulation utilizes a powder delivery system. Marketed by Alivus Life Sciences Limited, this product is identified by NDC 66039-945.

Identification & Billing

NDC Package Code
66039-945-04
Package Description
50 kg in 1 DRUM
Product Code
66039-945
11-Digit Billing Format
66039094504

Clinical Specifications

Proprietary Name
Gabapentin Enacarbil
Non-Proprietary Name
Gabapentin Enacarbil
Substance Name
Gabapentin Enacarbil
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
GABAPENTIN ENACARBIL 1 kg/kg
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
Alivus Life Sciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-02-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 66039-945-04 identifies a specific commercial package of 50 kg in 1 drum of Gabapentin Enacarbil (UNFINISHED drug), a bulk ingredient labeled by Alivus Life Sciences Limited. This powder is formulated for 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 Alivus Life Sciences Limited on November 02, 2018. The current certification is valid through December 31, 2027.

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 Alivus Life Sciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66039094504. 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)
66039-945-04
11-Digit CMS (5-4-2)
66039-0945-04

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