Austedo Xr Kit
NDC Package 68546-477-29

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 Xr (deutetrabenazine) kits is deutetrabenazine is used to decrease involuntary movements (chorea) caused by Huntington's disease. This formulation utilizes a kit delivery system. Marketed by Teva Neuroscience, Inc., this product is identified by NDC 68546-477 and is authorized under FDA application NDA216354.

Identification & Billing

NDC Package Code
68546-477-29
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)
Product Code
68546-477
11-Digit Billing Format
68546047729
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Austedo Xr
Non-Proprietary Name
Deutetrabenazine
Dosage Form
Kit - A packaged collection of related material.
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
07-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage
  • 68546 - Teva Neuroscience, Inc.
    • 68546-477 - Austedo Xr
      • 68546-477-29 - 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)

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 (68546-477). Click a package code to view its specific billing and regulatory data.

68546-477-28
1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)

* 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 68546-477-29 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack * 7 tablet, film coated, extended release in 1 blister pack (68546-192-07) * 7 tablet, film coated, extended release in 1 blister pack (68546-190-07) * 7 tablet, film coated, extended release in 1 blister pack (68546-193-07) * 7 tablet, film coated, extended release in 1 blister pack (68546-191-07) of Austedo Xr, a human prescription drug labeled by Teva Neuroscience, Inc.. This kit is formulated for use and contains 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 July 01, 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: 68546047729. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
68546-477-29
11-Digit CMS (5-4-2)
68546-0477-29

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