Austedo Tablet, Coated
NDC Package 68546-170-66

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

Package Information

Austedo (deutetrabenazine) tablets is deutetrabenazine is used to decrease involuntary movements (chorea) caused by Huntington's disease. This formulation utilizes a tablet, coated delivery system. Marketed by Teva Neuroscience, Inc., this product is identified by NDC 68546-170 and is authorized under FDA application NDA208082.

Identification & Billing

NDC Package Code
68546-170-66
Package Description
60 TABLET, COATED in 1 BOTTLE
Product Code
68546-170
11-Digit Billing Format
68546017066
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Austedo
Non-Proprietary Name
Deutetrabenazine
Substance Name
Deutetrabenazine
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEUTETRABENAZINE 6 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 #
NDA208082
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-12-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68546-170). Click a package code to view its specific billing and regulatory data.

68546-170-60
60 TABLET, COATED in 1 BOTTLE

* 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 68546-170-66 identifies a specific commercial package of 60 tablet, coated in 1 bottle of Austedo, a human prescription drug labeled by Teva Neuroscience, Inc.. This tablet, coated 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 April 12, 2017. 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: 68546017066. 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)
68546-170-66
11-Digit CMS (5-4-2)
68546-0170-66

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