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  5. NDC Package Code: 68546-470-56 Austedo Xr

NDC Package 68546-470-56 Austedo Xr

Deutetrabenazine Tablet, Film Coated, Extended Release 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:
68546-470-56
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
68546-470
Proprietary Name:
Austedo Xr
Non-Proprietary Name:
Deutetrabenazine
Substance Name:
Deutetrabenazine
Usage Information:
Deutetrabenazine is used to decrease involuntary movements (chorea) caused by Huntington's disease. It is also used to treat involuntary movements of the face, tongue, or other body parts (tardive dyskinesia). However, it is not a cure for the Huntington's disease or tardive dyskinesia. Reducing involuntary movements will help you take part in more of your normal daily activities. This medication is thought to work by decreasing the amount of certain natural substances in the brain that affect how your nerves and muscles work (monoamines such as dopamine, serotonin, and norepinephrine).
11-Digit NDC Billing Format:
68546047056
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1876910 - deutetrabenazine 12 MG Oral Tablet
  • RxCUI: 1876916 - Austedo 12 MG Oral Tablet
  • RxCUI: 1876916 - deutetrabenazine 12 MG Oral Tablet [Austedo]
  • RxCUI: 1876918 - deutetrabenazine 6 MG Oral Tablet
  • RxCUI: 1876920 - Austedo 6 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Teva Neuroscience, Inc.
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEUTETRABENAZINE 6 mg/1
    • Sample Package:
    No
    FDA Application Number:
    NDA216354
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-21-2023
    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 68546-470-56?

    The NDC Packaged Code 68546-470-56 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle of Austedo Xr, a human prescription drug labeled by Teva Neuroscience, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 68546-470 included in the NDC Directory?

    Yes, Austedo Xr with product code 68546-470 is active and included in the NDC Directory. The product was first marketed by Teva Neuroscience, Inc. on February 21, 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 68546-470-56?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 68546-470-56?

    The 11-digit format is 68546047056. 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
    5-3-268546-470-565-4-268546-0470-56