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  5. NDC Package Code: 0054-9628-57 Sodium Oxybate

NDC Package 0054-9628-57 Sodium Oxybate

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0054-9628-57
Package Description:
180 mL in 1 BOTTLE, PLASTIC
Product Code:
0054-9628
Proprietary Name:
Sodium Oxybate
Non-Proprietary Name:
Sodium Oxybate
Substance Name:
Sodium Oxybate
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).
11-Digit NDC Billing Format:
00054962857
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
180 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 349482 - sodium oxybate 500 MG in 1 mL Oral Solution
  • RxCUI: 349482 - sodium oxybate 500 MG/ML Oral Solution
  • RxCUI: 349482 - sodium oxybate 500 MG per 1 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hikma Pharmaceuticals Usa Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM OXYBATE .5 g/mL
    • Pharmacologic Class(es):
  • Central Nervous System Depressant - [EPC] (Established Pharmacologic Class)
  • Central Nervous System Depression - [PE] (Physiologic Effect)
  • Decreased Central Nervous System Organized Electrical Activity - [PE] (Physiologic Effect)
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0054-9628-57?

    The NDC Packaged Code 0054-9628-57 is assigned to a package of 180 ml in 1 bottle, plastic of Sodium Oxybate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 180 billable units per package.

    Is NDC 0054-9628 included in the NDC Directory?

    Yes, Sodium Oxybate with product code 0054-9628 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on January 03, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0054-9628-57?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 180.

    What is the 11-digit format for NDC 0054-9628-57?

    The 11-digit format is 00054962857. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20054-9628-575-4-200054-9628-57