Trifluoperazine Hydrochloride Tablet, Film Coated
NDC Package 0378-2402-01

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

Package Information

Trifluoperazine Hydrochloride tablets is for the management of schizophrenia.Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. This formulation utilizes a tablet, film coated delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-2402 and is authorized under FDA application ANDA040209.

Identification & Billing

NDC Package Code
0378-2402-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
0378-2402
11-Digit Billing Format
00378240201
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
Trifluoperazine Hydrochloride
Non-Proprietary Name
Trifluoperazine Hydrochloride
Substance Name
Trifluoperazine Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRIFLUOPERAZINE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
For the management of schizophrenia.Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines).When used in the treatment of non-psychotic anxiety, trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of trifluoperazine hydrochloride tablets as a treatment for non-psychotic anxiety was established in a 4-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine hydrochloride tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Trifluoperazine hydrochloride tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040209
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-29-1997
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 0378-2402-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle, plastic of Trifluoperazine Hydrochloride, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet, film coated is formulated for oral use and contains trifluoperazine hydrochloride 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 Mylan Pharmaceuticals Inc. on August 29, 1997. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378240201. 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 (4-4-2)
0378-2402-01
11-Digit CMS (5-4-2)
00378-2402-01

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