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  5. NDC Package Code: 53489-500-60 Thioridazine Hydrochloride

NDC Package 53489-500-60 Thioridazine Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53489-500-60
Package Description:
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
53489-500
Proprietary Name:
Thioridazine Hydrochloride
Non-Proprietary Name:
Thioridazine Hydrochloride
Substance Name:
Thioridazine Hydrochloride
Usage Information:
Thioridazine hydrochloride tablets are 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 hydrochloride tablets 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 hydrochloride tablets, 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 WARNINGS and CONTRAINDICATIONS).However, the prescriber should be aware that thioridazine hydrochloride tablets have not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.
11-Digit NDC Billing Format:
53489050060
NDC to RxNorm Crosswalk:
  • RxCUI: 198270 - thioridazine HCl 100 MG Oral Tablet
  • RxCUI: 198270 - thioridazine 100 MG Oral Tablet
  • RxCUI: 198274 - thioridazine HCl 25 MG Oral Tablet
  • RxCUI: 198274 - thioridazine 25 MG Oral Tablet
  • RxCUI: 198274 - thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • THIORIDAZINE HYDROCHLORIDE 100 mg/1
    • Pharmacologic Class(es):
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA089953
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-07-1988
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    53489-500-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    53489-500-0250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    53489-500-03250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    53489-500-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    53489-500-0660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
    53489-500-101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53489-500-60?

    The NDC Packaged Code 53489-500-60 is assigned to a package of 20 tablet, film coated in 1 bottle, plastic of Thioridazine Hydrochloride, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 53489-500 included in the NDC Directory?

    Yes, Thioridazine Hydrochloride with product code 53489-500 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on October 07, 1988 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53489-500-60?

    The 11-digit format is 53489050060. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253489-500-605-4-253489-0500-60