NDC Package 69584-674-03 Paroxetine 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:
69584-674-03
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Paroxetine Hydrochloride
Non-Proprietary Name:
Paroxetine Hydrochloride
Substance Name:
Paroxetine Hydrochloride
Usage Information:
Paroxetine is contraindicated in patients:Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3) and Drug Interactions (7)].Taking pimozide because of risk of QT prolongation[see Warnings and Precautions (5.3), Drug Interactions (7)].With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets, USP[see Adverse Reactions (6.1), (6.2)].
11-Digit NDC Billing Format:
69584067403
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
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Oxford Pharmaceuticals, Llc
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA076968
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-14-2022
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    69584-674-0990 TABLET, FILM COATED in 1 BOTTLE
    69584-674-10100 TABLET, FILM COATED in 1 BOTTLE
    69584-674-50500 TABLET, FILM COATED in 1 BOTTLE
    69584-674-901000 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69584-674-03?

    The NDC Packaged Code 69584-674-03 is assigned to a package of 30 tablet, film coated in 1 bottle of Paroxetine Hydrochloride, a human prescription drug labeled by Oxford Pharmaceuticals, Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 69584-674 included in the NDC Directory?

    Yes, Paroxetine Hydrochloride with product code 69584-674 is active and included in the NDC Directory. The product was first marketed by Oxford Pharmaceuticals, Llc on November 14, 2022 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 69584-674-03?

    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 69584-674-03?

    The 11-digit format is 69584067403. 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
    5-3-269584-674-035-4-269584-0674-03