Tetrabenazine Tablet, Coated
NDC Package 31722-821-31

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

Tetrabenazine tablets is tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. This formulation utilizes a tablet, coated delivery system. Marketed by Camber Pharmaceuticals, Inc., this product is identified by NDC 31722-821 and is authorized under FDA application ANDA204574.

Identification & Billing

NDC Package Code
31722-821-31
Package Description
10 TABLET, COATED in 1 BLISTER PACK
Product Code
31722-821
11-Digit Billing Format
31722082131
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tetrabenazine
Non-Proprietary Name
Tetrabenazine
Substance Name
Tetrabenazine
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)
TETRABENAZINE 12.5 mg/1
Pharmacologic Class
Usage Information
Tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. However, it is not a cure for the disease. Reducing the chorea 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 (monoamines such as dopamine, serotonin, and norepinephrine), which are involved with nerve and muscle function. Tetrabenazine belongs to a class of drugs called monoamine depletors.

Regulatory & Marketing

Labeler Name
Camber Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204574
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-17-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (31722-821). Click a package code to view its specific billing and regulatory data.

31722-821-11
112 TABLET, COATED in 1 BOTTLE
31722-821-32
100 TABLET, COATED in 1 CARTON
31722-821-56
56 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 31722-821-31 identifies a specific commercial package of 10 tablet, coated in 1 blister pack of Tetrabenazine, a human prescription drug labeled by Camber Pharmaceuticals, Inc.. This tablet, coated is formulated for oral use and contains tetrabenazine 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 Camber Pharmaceuticals, Inc. on August 17, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. However, it is not a cure for the disease. Reducing the chorea 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 (monoamines such as dopamine, serotonin, and norepinephrine), which are involved with nerve and muscle function. Tetrabenazine belongs to a class of drugs called monoamine depletors.

How is this Camber Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31722082131. 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)
31722-821-31
11-Digit CMS (5-4-2)
31722-0821-31

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