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  5. NDC Package Code: 0781-8034-01 Trifluoperazine Hydrochloride

NDC Package 0781-8034-01 Trifluoperazine Hydrochloride

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

Table of Contents

    1. Package Information
    2. 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:
0781-8034-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0781-8034
Proprietary Name:
Trifluoperazine Hydrochloride
Non-Proprietary Name:
Trifluoperazine Hydrochloride
Substance Name:
Trifluoperazine Hydrochloride
Usage Information:
For the management of schizophrenia.Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is 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 HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl 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 HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.
11-Digit NDC Billing Format:
00781803401
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
Product Type:
Human Prescription Drug
Labeler Name:
Sandoz 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):
  • TRIFLUOPERAZINE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA085789
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-20-1981
    End Marketing Date:
    03-19-2027
    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 0781-8034-01?

    The NDC Packaged Code 0781-8034-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Trifluoperazine Hydrochloride, a human prescription drug labeled by Sandoz Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0781-8034 included in the NDC Directory?

    Yes, Trifluoperazine Hydrochloride with product code 0781-8034 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc. on November 20, 1981.

    What is the NDC billing unit for package 0781-8034-01?

    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 0781-8034-01?

    The 11-digit format is 00781803401. 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 4-4-2 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
    4-4-20781-8034-015-4-200781-8034-01