Sodium Oxybate For Suspension, Extended Release
NDC Package 82646-005-01

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.

Sodium Oxybate for suspensions is a medication used to treat narcolepsy, a condition that causes severe daytime sleepiness. This formulation utilizes a for suspension, extended release delivery system. Marketed by Meribel Pharma Pessac, this product is identified by NDC 82646-005.

Identification & Billing

NDC Package Code
82646-005-01
Package Description
6 CARTON in 1 BOX / 80 PACKET in 1 CARTON / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
Product Code
82646-005
11-Digit Billing Format
82646000501

Clinical Specifications

Proprietary Name
Sodium Oxybate
Non-Proprietary Name
Sodium Oxybate
Substance Name
Sodium Oxybate
Dosage Form
For Suspension, Extended Release - A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period.
Active Ingredient(s)
SODIUM OXYBATE 4.5 g/1
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 III (CIII) Substances

Regulatory & Marketing

Labeler Name
Meribel Pharma Pessac
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-01-2023
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 82646-005-01 identifies a specific commercial package of 6 carton in 1 box / 80 packet in 1 carton / 1 for suspension, extended release in 1 packet of Sodium Oxybate (UNFINISHED drug), drug for further processing labeled by Meribel Pharma Pessac. This for suspension, extended release 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 Meribel Pharma Pessac on May 01, 2023. 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 Meribel Pharma Pessac product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82646000501. 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)
82646-005-01
11-Digit CMS (5-4-2)
82646-0005-01

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