Tetrabenazine
NDC Package 0054-0469-23

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

Package Information

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

Tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0469 and is authorized under FDA application ANDA209739.

Identification & Billing

NDC Package Code
0054-0469-23
Package Description
112 TABLET in 1 BOTTLE
Product Code
0054-0469
11-Digit Billing Format
00054046923
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
112 EA

Clinical Specifications

Proprietary Name
Tetrabenazine
Dosage Form
-
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
Hikma Pharmaceuticals Usa Inc.
FDA Application #
ANDA209739
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-19-2019
End Marketing Date
05-31-2021
Listing Expiration
05-31-2021
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-0469-23 identifies a specific commercial package of 112 tablet in 1 bottle of Tetrabenazine, labeled by Hikma Pharmaceuticals Usa Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 112 billable units per package. 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 Hikma Pharmaceuticals Usa Inc. on September 19, 2019. The current certification is valid through May 31, 2021.

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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054046923. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 112 total billable units per package. 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 (4-4-2)
0054-0469-23
11-Digit CMS (5-4-2)
00054-0469-23

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