Xenazine Tablet
NDC Package 67386-421-01

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

Package Information

Xenazine (tetrabenazine) tablets is tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. This formulation utilizes a tablet delivery system. Marketed by Lundbeck Pharmaceuticals Llc, this product is identified by NDC 67386-421 and is authorized under FDA application NDA021894.

Identification & Billing

NDC Package Code
67386-421-01
Package Description
112 TABLET in 1 BOTTLE
Product Code
67386-421
11-Digit Billing Format
67386042101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
112 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xenazine
Non-Proprietary Name
Tetrabenazine
Substance Name
Tetrabenazine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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
Lundbeck Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021894
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-24-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67386-421-01 identifies a specific commercial package of 112 tablet in 1 bottle of Xenazine, a human prescription drug labeled by Lundbeck Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 112 billable units per package. This tablet 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 Lundbeck Pharmaceuticals Llc on November 24, 2008. 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 Lundbeck Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67386042101. 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 (5-3-2)
67386-421-01
11-Digit CMS (5-4-2)
67386-0421-01

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