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  5. NDC Package Code: 68084-047-01 Paroxetine

NDC Package 68084-047-01 Paroxetine

Paroxetine 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:
68084-047-01
Package Description:
100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-047-11)
Product Code:
68084-047
Proprietary Name:
Paroxetine
Non-Proprietary Name:
Paroxetine Hydrochloride
Substance Name:
Paroxetine Hydrochloride Hemihydrate
Usage Information:
The use of MAOIs intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting paroxetine tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION). Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets.
11-Digit NDC Billing Format:
68084004701
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: 1738483 - PARoxetine HCl 10 MG Oral Tablet
  • RxCUI: 1738483 - paroxetine hydrochloride 10 MG Oral Tablet
  • RxCUI: 1738495 - PARoxetine HCl 20 MG Oral Tablet
  • RxCUI: 1738495 - paroxetine hydrochloride 20 MG Oral Tablet
  • RxCUI: 1738503 - PARoxetine HCl 30 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    American Health Packaging
    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):
  • PAROXETINE HYDROCHLORIDE HEMIHYDRATE 40 mg/1
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077584
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-18-2008
    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 68084-047-01?

    The NDC Packaged Code 68084-047-01 is assigned to a package of 100 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack (68084-047-11) of Paroxetine, a human prescription drug labeled by American Health Packaging. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 68084-047 included in the NDC Directory?

    Yes, Paroxetine with product code 68084-047 is active and included in the NDC Directory. The product was first marketed by American Health Packaging on June 18, 2008 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 68084-047-01?

    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 68084-047-01?

    The 11-digit format is 68084004701. 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
    5-3-268084-047-015-4-268084-0047-01