Austedo Xr
NDC Package 68546-490-52

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Austedo Xr is aUSTEDO® is indicated in adults for the treatment of:chorea associated with Huntington’s disease [see Clinical Studies (14.1)]tardive dyskinesia [see Clinical Studies (14.2)]. Marketed by Teva Neuroscience, Inc., this product is identified by NDC 68546-490 and is authorized under FDA application NDA216354.

Identification & Billing

NDC Package Code
68546-490-52
Package Description
2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15)
Product Code
68546-490
11-Digit Billing Format
68546049052
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
Dosage Form
-
Usage Information
AUSTEDO® is indicated in adults for the treatment of:chorea associated with Huntington’s disease [see Clinical Studies (14.1)]tardive dyskinesia [see Clinical Studies (14.2)]

Regulatory & Marketing

Labeler Name
Teva Neuroscience, Inc.
FDA Application #
NDA216354
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-21-2023
End Marketing Date
06-30-2025
Listing Expiration
06-30-2025
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage
  • 68546 - Teva Neuroscience, Inc.
    • 68546-490 - Austedo Xr
      • 68546-490-52 - 2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15)

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 (68546-490). Click a package code to view its specific billing and regulatory data.

68546-490-42
2 KIT in 1 BLISTER PACK / 1 KIT in 1 KIT * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-163-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-165-15) * 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-161-15)

* 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 68546-490-52 identifies a specific commercial package of 2 blister pack in 1 carton / 1 kit in 1 blister pack * 14 tablet, film coated, extended release in 1 blister pack (68546-163-15) * 14 tablet, film coated, extended release in 1 blister pack (68546-165-15) * 14 tablet, film coated, extended release in 1 blister pack (68546-161-15) of Austedo Xr, labeled by Teva Neuroscience, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Teva Neuroscience, Inc. on February 21, 2023. The current certification is valid through June 30, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68546049052. 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)
68546-490-52
11-Digit CMS (5-4-2)
68546-0490-52

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