Paroxetine Tablet, Film Coated
NDC Package 43353-554-45

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Paroxetine (paroxetine hydrochloride hemihydrate) tablets is 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-554 and is authorized under FDA application ANDA078902.

Identification & Billing

NDC Package Code
43353-554-45
Package Description
45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
43353-554
11-Digit Billing Format
43353055445
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
45 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paroxetine
Non-Proprietary Name
Paroxetine Hydrochloride Hemihydrate
Substance Name
Paroxetine Hydrochloride Hemihydrate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA078902
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43353-554). Click a package code to view its specific billing and regulatory data.

43353-554-15
15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
43353-554-30
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43353-554-45 identifies a specific commercial package of 45 tablet, film coated in 1 bottle, plastic of Paroxetine, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 45 billable units per package. This tablet, film coated is formulated for oral use and contains paroxetine hydrochloride hemihydrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on March 24, 2008. The current certification is valid through December 31, 2026.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353055445. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 45 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
43353-554-45
11-Digit CMS (5-4-2)
43353-0554-45

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.