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  5. NDC Package Code: 68727-150-01 Xywav

NDC Package 68727-150-01 Xywav

(calcium,Magnesium,Potassium,And Sodium Oxybates) 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:
68727-150-01
Package Description:
180 mL in 1 BOTTLE, PLASTIC
Product Code:
68727-150
Proprietary Name:
Xywav
Non-Proprietary Name:
(calcium, Magnesium, Potassium, And Sodium Oxybates)
Substance Name:
Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate
Usage Information:
XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
11-Digit NDC Billing Format:
68727015001
NDC to RxNorm Crosswalk:
  • RxCUI: 2393794 - xywav 0.5 GM in 1 mL Oral Solution
  • RxCUI: 2393794 - calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / potassium oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]
  • RxCUI: 2393794 - calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / K+ oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]
  • RxCUI: 2393794 - calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / Pot oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]
  • RxCUI: 2393794 - Xywav (calcium oxybate 0.234 GM / magnesium oxybate 0.096 GM / potassium oxybate 0.13 GM / sodium oxybate 0.04 GM) per 1 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Jazz Pharmaceuticals, 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):
  • CALCIUM OXYBATE .5 g/mL
  • MAGNESIUM OXYBATE .5 g/mL
  • POTASSIUM OXYBATE .5 g/mL
  • SODIUM OXYBATE .5 g/mL
    • Pharmacologic Class(es):
  • Central Nervous System Depressant - [EPC] (Established Pharmacologic Class)
  • 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:
    NDA212690
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-02-2020
    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 68727-150-01?

    The NDC Packaged Code 68727-150-01 is assigned to a package of 180 ml in 1 bottle, plastic of Xywav, a human prescription drug labeled by Jazz Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 68727-150 included in the NDC Directory?

    Yes, Xywav with product code 68727-150 is active and included in the NDC Directory. The product was first marketed by Jazz Pharmaceuticals, Inc. on November 02, 2020 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 11-digit format for NDC 68727-150-01?

    The 11-digit format is 68727015001. 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 5-3-2 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
    5-3-268727-150-015-4-268727-0150-01