Pimozide Tablet
NDC Package 49884-348-01

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

Package Information

Pimozide tablets is a medication used to reduce uncontrolled movements (motor tics) or outbursts of words/sounds (vocal tics) caused by Tourette syndrome. This formulation utilizes a tablet delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 49884-348 and is authorized under FDA application ANDA204521.

Identification & Billing

NDC Package Code
49884-348-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
49884-348
11-Digit Billing Format
49884034801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pimozide
Non-Proprietary Name
Pimozide
Substance Name
Pimozide
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)
PIMOZIDE 2 mg/1
Pharmacologic Class
Typical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
This medication is used to reduce uncontrolled movements (motor tics) or outbursts of words/sounds (vocal tics) caused by Tourette syndrome. Pimozide is a medication that works by decreasing the activity of a natural substance (dopamine) in the brain. Pimozide should not be used for mild symptoms. It should only be used if symptoms cause severe problems in everyday life and other medicines or treatments have not been effective.

Regulatory & Marketing

Labeler Name
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA204521
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-28-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49884-348-01 identifies a specific commercial package of 100 tablet in 1 bottle of Pimozide, a human prescription drug labeled by Endo Usa, Inc.. This tablet is formulated for oral use and contains pimozide 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 Endo Usa, Inc. on September 28, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to reduce uncontrolled movements (motor tics) or outbursts of words/sounds (vocal tics) caused by Tourette syndrome. Pimozide is a medication that works by decreasing the activity of a natural substance (dopamine) in the brain. Pimozide should not be used for mild symptoms. It should only be used if symptoms cause severe problems in everyday life and other medicines or treatments have not been effective.

How is this Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884034801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
49884-348-01
11-Digit CMS (5-4-2)
49884-0348-01

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