Austedo Xr Tablet, Film Coated, Extended Release
NDC Package 68546-474-56

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

Package Information

Austedo Xr (deutetrabenazine) tablets is deutetrabenazine is used to decrease involuntary movements (chorea) caused by Huntington's disease. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Teva Neuroscience, Inc., this product is identified by NDC 68546-474 and is authorized under FDA application NDA216354.

Identification & Billing

NDC Package Code
68546-474-56
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
68546-474
11-Digit Billing Format
68546047456
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Austedo Xr
Non-Proprietary Name
Deutetrabenazine
Substance Name
Deutetrabenazine
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEUTETRABENAZINE 36 mg/1
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).

Regulatory & Marketing

Labeler Name
Teva Neuroscience, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA216354
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-29-2024
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 68546-474-56 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Austedo Xr, a human prescription drug labeled by Teva Neuroscience, Inc.. This tablet, film coated, extended release is formulated for oral use and contains deutetrabenazine 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 Teva Neuroscience, Inc. on May 29, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Teva Neuroscience, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68546047456. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-3-2)
68546-474-56
11-Digit CMS (5-4-2)
68546-0474-56

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