Paroxetine Tablet, Film Coated, Extended Release
NDC Package 42858-705-50

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Paroxetine (paroxetine hydrochloride hemihydrate) tablets is the use of MAOIs intended to treat psychiatric disorders with paroxetine extended-release tablets or within 14 days of stopping treatment with paroxetine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Rhodes Pharmaceuticals Llc, this product is identified by NDC 42858-705 and is authorized under FDA application ANDA209293.

Identification & Billing

NDC Package Code
42858-705-50
Package Description
500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
42858-705
11-Digit Billing Format
42858070550
RxNorm Crosswalk
  • RxCUI: 1738803 - PARoxetine HCl 12.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1738803 - 24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet
  • RxCUI: 1738803 - paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1738805 - PARoxetine HCl 25 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1738805 - 24 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Paroxetine
Non-Proprietary Name
Paroxetine Hydrochloride Hemihydrate
Substance Name
Paroxetine Hydrochloride
Dosage Form
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PAROXETINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
The use of MAOIs intended to treat psychiatric disorders with paroxetine extended-release tablets or within 14 days of stopping treatment with paroxetine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION).Starting paroxetine extended-release 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 extended-release tablets are contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in paroxetine extended-release tablets.

Regulatory & Marketing

Labeler Name
Rhodes Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209293
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-14-2018
End Marketing Date
07-31-2026
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 (42858-705). Click a package code to view its specific billing and regulatory data.

42858-705-03
30 TABLET, FILM COATED, EXTENDED RELEASE 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 42858-705-50 identifies a specific commercial package of 500 tablet, film coated, extended release in 1 bottle of Paroxetine, a human prescription drug labeled by Rhodes Pharmaceuticals Llc. This tablet, film coated, extended release is formulated for oral use and contains paroxetine hydrochloride 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 Rhodes Pharmaceuticals Llc on September 14, 2018.

How is this Rhodes Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42858070550. 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)
42858-705-50
11-Digit CMS (5-4-2)
42858-0705-50

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