Gamma Hydroxybutyric Acid Powder
NDC Package 17180-2010-0

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.

Gamma Hydroxybutyric Acid powders is a medication used to treat narcolepsy, a condition that causes severe daytime sleepiness. This formulation utilizes a powder delivery system. Marketed by Curia Missouri, Inc., this product is identified by NDC 17180-2010.

Identification & Billing

NDC Package Code
17180-2010-0
Package Description
13 kg in 1 DRUM
Product Code
17180-2010
11-Digit Billing Format
17180201000

Clinical Specifications

Proprietary Name
Gamma Hydroxybutyric Acid
Non-Proprietary Name
Gamma Hydroxybutyric Acid
Substance Name
Sodium Oxybate
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)
SODIUM OXYBATE 13 kg/13kg
Usage Information
This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. Sodium oxybate can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).
DEA Schedule
Schedule I (CI) Substance

Regulatory & Marketing

Labeler Name
Curia Missouri, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
07-17-2002
Listing Expiration
12-31-2026
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 17180-2010-0 identifies a specific commercial package of 13 kg in 1 drum of Gamma Hydroxybutyric Acid (UNFINISHED drug), a bulk ingredient labeled by Curia Missouri, Inc.. This powder is formulated for use and contains sodium oxybate 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 Curia Missouri, Inc. on July 17, 2002. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat narcolepsy, a condition that causes severe daytime sleepiness. Sodium oxybate can decrease daytime sleepiness and also reduce the number of sudden short attacks of weak/paralyzed muscles (known as cataplexy) that can occur in patients with narcolepsy. Sodium oxybate is a central nervous system depressant. It is also known as gamma hydroxybutyrate (GHB).

How is this Curia Missouri, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17180201000. 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)
17180-2010-0
11-Digit CMS (5-4-2)
17180-2010-00

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