NDC Package 51079-565-20 Thioridazine Hydrochloride

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

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:
51079-565-20
Package Description:
100 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-565-01)
Product Code:
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:
51079056520
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
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:
    Mylan Institutional 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.
  • Sample Package:
    No
    FDA Application Number:
    ANDA088004
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-29-1998
    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.

    Frequently Asked Questions

    What is NDC 51079-565-20?

    The NDC Packaged Code 51079-565-20 is assigned to a package of 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack (51079-565-01) of Thioridazine Hydrochloride, a human prescription drug labeled by Mylan Institutional Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 51079-565 included in the NDC Directory?

    Yes, Thioridazine Hydrochloride with product code 51079-565 is active and included in the NDC Directory. The product was first marketed by Mylan Institutional Inc. on April 29, 1998 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 NDC billing unit for package 51079-565-20?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 51079-565-20?

    The 11-digit format is 51079056520. 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
    5-3-251079-565-205-4-251079-0565-20