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  5. NDC Package Code: 54458-989-16 Paroxetine

NDC Package 54458-989-16 Paroxetine

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
54458-989-16
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
54458-989
Proprietary Name:
Paroxetine
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:
54458098916
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 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
    • Labeler Name:
    International Laboratories, Llc
    Sample Package:
    No
    Start Marketing Date:
    12-11-2007
    Listing Expiration Date:
    12-31-2020
    Exclude Flag:
    I
    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 54458-989-16?

    The NDC Packaged Code 54458-989-16 is assigned to a package of 30 tablet in 1 bottle of Paroxetine, labeled by International Laboratories, Llc. The product's dosage form is and is administered via form.

    Is NDC 54458-989 included in the NDC Directory?

    No, Paroxetine with product code 54458-989 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by International Laboratories, Llc on December 11, 2007 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54458-989-16?

    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 30.

    What is the 11-digit format for NDC 54458-989-16?

    The 11-digit format is 54458098916. 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
    5-3-254458-989-165-4-254458-0989-16