Paroxetine
NDC Package 57315-044-01

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Paroxetine is a . Marketed by Alphapharm Pty. Ltd., this product is identified by NDC 57315-044 and is authorized under FDA application ANDA075716.

Identification & Billing

NDC Package Code
57315-044-01
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
57315-044
11-Digit Billing Format
57315004401

Clinical Specifications

Proprietary Name
Paroxetine
Dosage Form
-

Regulatory & Marketing

Labeler Name
Alphapharm Pty. Ltd.
FDA Application #
ANDA075716
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2010
End Marketing Date
01-01-2013
Listing Expiration
01-01-2013
Exclude Flag
D
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 (57315-044). Click a package code to view its specific billing and regulatory data.

57315-044-02
100 TABLET, FILM COATED in 1 BOTTLE
57315-044-03
1000 TABLET, FILM COATED in 1 BOTTLE

* 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 57315-044-01 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Paroxetine, labeled by Alphapharm Pty. Ltd.. 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 Alphapharm Pty. Ltd. on January 01, 2010. The current certification is valid through January 01, 2013.

How is this Alphapharm Pty. Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57315004401. 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)
57315-044-01
11-Digit CMS (5-4-2)
57315-0044-01

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