Paroxetine
NDC Package 16590-181-28
Package Information
Paroxetine is the use of MAOIs intended to treat depression with, or within 14 days of treatment with, paroxetine tablets is contraindicated (see WARNINGS). Do not start paroxetine tablets in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS). 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. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-181 and is authorized under FDA application ANDA078406.
Identification & Billing
- RxCUI: 1738495 - PARoxetine HCl 20 MG Oral Tablet
- RxCUI: 1738495 - paroxetine hydrochloride 20 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 16590 - Stat Rx Usa Llc
- 16590-181 - Paroxetine
- 16590-181-28 - 28 TABLET, FILM COATED in 1 BOTTLE
- 16590-181 - Paroxetine
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 (16590-181). Click a package code to view its specific billing and regulatory data.
* 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 16590-181-28 identifies a specific commercial package of 28 tablet, film coated in 1 bottle of Paroxetine, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 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 Stat Rx Usa Llc on July 25, 2007. The current certification is valid through December 31, 2017.
How is this Stat Rx Usa Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590018128. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
