Sodium Oxybate Solution
NDC Package 0054-9628-57

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sodium Oxybate solution is a medication used to treat narcolepsy, a condition that causes severe daytime sleepiness. This formulation utilizes a solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-9628 and is authorized under FDA application NDA021196.

Identification & Billing

NDC Package Code
0054-9628-57
Package Description
180 mL in 1 BOTTLE, PLASTIC
Product Code
0054-9628
11-Digit Billing Format
00054962857
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
180 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Oxybate
Non-Proprietary Name
Sodium Oxybate
Substance Name
Sodium Oxybate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM OXYBATE .5 g/mL
Pharmacologic Class
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
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA021196
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
01-03-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-9628-57 identifies a specific commercial package of 180 ml in 1 bottle, plastic of Sodium Oxybate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 180 billable units per package. This solution is formulated for oral 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 Hikma Pharmaceuticals Usa Inc. on January 03, 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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054962857. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 180 total billable units per package. 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 (4-4-2)
0054-9628-57
11-Digit CMS (5-4-2)
00054-9628-57

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