1. Home
  2. Labeler Index
  3. Remedyrepack Inc.
  4. 70518-2095
  5. NDC Package Code: 70518-2095-0 Trifluoperazine Hydrochloride

NDC Package 70518-2095-0 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:
70518-2095-0
Package Description:
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
70518-2095
Proprietary Name:
Trifluoperazine Hydrochloride
Non-Proprietary Name:
Trifluoperazine Hydrochloride
Substance Name:
Trifluoperazine Hydrochloride
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.
11-Digit NDC Billing Format:
70518209500
NDC to RxNorm Crosswalk:
  • RxCUI: 198324 - trifluoperazine HCl 2 MG Oral Tablet
  • RxCUI: 198324 - trifluoperazine 2 MG Oral Tablet
  • RxCUI: 198324 - trifluoperazine (as trifluoperazine hydrochloride) 2 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Remedyrepack 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 2 mg/1
    • Pharmacologic Class(es):
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA040209
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-21-2019
    Listing Expiration Date:
    12-31-2025
    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 70518-2095-0?

    The NDC Packaged Code 70518-2095-0 is assigned to a package of 30 tablet, film coated in 1 blister pack of Trifluoperazine Hydrochloride, a human prescription drug labeled by Remedyrepack Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 70518-2095 included in the NDC Directory?

    Yes, Trifluoperazine Hydrochloride with product code 70518-2095 is active and included in the NDC Directory. The product was first marketed by Remedyrepack Inc. on May 21, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 70518-2095-0?

    The 11-digit format is 70518209500. 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 5-4-1 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
    5-4-170518-2095-05-4-270518-2095-00