Paroxetine
NDC Package 70934-222-30

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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals, this product is identified by NDC 70934-222 and is authorized under FDA application ANDA077584.

Identification & Billing

NDC Package Code
70934-222-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
70934-222
11-Digit Billing Format
70934022230
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 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
Denton Pharma, Inc. Dba Northwind Pharmaceuticals
FDA Application #
ANDA077584
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-08-2019
Listing Expiration
12-31-2020
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 70934-222-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Paroxetine, labeled by Denton Pharma, Inc. Dba Northwind Pharmaceuticals. 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 Denton Pharma, Inc. Dba Northwind Pharmaceuticals on January 08, 2019. The current certification is valid through December 31, 2020.

How is this Denton Pharma, Inc. Dba Northwind Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70934022230. 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)
70934-222-30
11-Digit CMS (5-4-2)
70934-0222-30

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