Tetrabenzine Powder
NDC Package 42413-0049-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tetrabenzine powders is tetrabenazine is used to decrease the uncontrollable movements (chorea) caused by Huntington's disease. This formulation utilizes a powder delivery system. Marketed by Enaltec Labs Private Limited, this product is identified by NDC 42413-0049.

Identification & Billing

NDC Package Code
42413-0049-1
Package Description
5.46 kg in 1 BAG
Product Code
42413-0049
11-Digit Billing Format
42413004901

Clinical Specifications

Proprietary Name
Tetrabenzine
Non-Proprietary Name
Tetrabenzine
Substance Name
Tetrabenazine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
TETRABENAZINE 5.46 kg/5.46kg
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
Enaltec Labs Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-28-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 42413-0049-1 identifies a specific commercial package of 5.46 kg in 1 bag of Tetrabenzine (UNFINISHED drug), a bulk ingredient labeled by Enaltec Labs Private Limited. This powder is formulated for 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 Enaltec Labs Private Limited on November 28, 2017. 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 Enaltec Labs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42413004901. 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 (5-4-1)
42413-0049-1
11-Digit CMS (5-4-2)
42413-0049-01

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