Thioridazine Hydrochloride Tablet, Film Coated
NDC Package 62135-939-90

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

Package Information

Thioridazine Hydrochloride tablets is thioridazine is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. This formulation utilizes a tablet, film coated delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-939 and is authorized under FDA application ANDA088135.

Identification & Billing

NDC Package Code
62135-939-90
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
62135-939
11-Digit Billing Format
62135093990
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thioridazine Hydrochloride
Non-Proprietary Name
Thioridazine Hydrochloride
Substance Name
Thioridazine 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)
THIORIDAZINE HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Usage Information
Thioridazine is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine, it is strongly recommended that a patient be given at least two trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration (see WARNINGSand CONTRAINDICATIONS). However, the prescriber should be aware that thioridazine has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA088135
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-1984
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 62135-939-90 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Thioridazine Hydrochloride, a human prescription drug labeled by Chartwell Rx, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet, film coated is formulated for oral use and contains thioridazine 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 Chartwell Rx, Llc on November 20, 1984. The current certification is valid through December 31, 2026.

How is this Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135093990. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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)
62135-939-90
11-Digit CMS (5-4-2)
62135-0939-90

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