Austedo Xr Kit
NDC 68546-477

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 68546-477?
  4. Austedo Xr Uses
  5. NDC to RxNorm Crosswalk
  6. Patient Education

Product Information

Austedo Xr (deutetrabenazine) is a NDA-approved product labeled by Teva Neuroscience, Inc.. Deutetrabenazine is used to decrease involuntary movements (chorea) caused by Huntington's disease. It is supplied as a kit. This product entry covers the primary NDC 68546-477 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68546-477
Proprietary Name:
Austedo Xr
Non-Proprietary Name: [1]
Deutetrabenazine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Teva Neuroscience, Inc.
Labeler Code:
68546
Product Label ID:
7ea3c60a-45c7-44cc-afc2-d87fa53993c0
FDA Application Number: [6]
NDA216354
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-01-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 68546-477?

The NDC code 68546-477 is assigned by the FDA to the product Austedo Xr. It is commonly known by its generic name, deutetrabenazine. This pharmaceutical product is labeled by Teva Neuroscience, Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 68546-477-28, 68546-477-29. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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).

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Deutetrabenazine


Deutetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). It is also used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Deutetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".