Paroxetine
NDC Package 10544-809-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Paroxetine 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. Marketed by Blenheim Pharmacal, Inc., this product is identified by NDC 10544-809 and is authorized under FDA application ANDA075356.

Identification & Billing

NDC Package Code
10544-809-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
10544-809
11-Digit Billing Format
10544080930
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paroxetine
Dosage Form
-
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 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, USP are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets, USP.

Regulatory & Marketing

Labeler Name
Blenheim Pharmacal, Inc.
FDA Application #
ANDA075356
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-06-2014
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10544-809-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Paroxetine, labeled by Blenheim Pharmacal, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Blenheim Pharmacal, Inc. on February 06, 2014. The current certification is valid through December 31, 2017.

How is this Blenheim Pharmacal, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10544080930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
10544-809-30
11-Digit CMS (5-4-2)
10544-0809-30

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