Paxil Tablet, Film Coated, Extended Release
NDC Package 60505-4378-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Paxil (paroxetine hydrochloride) tablets is paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Apotex Corp, this product is identified by NDC 60505-4378 and is authorized under FDA application NDA020936.

Identification & Billing

NDC Package Code
60505-4378-3
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
60505-4378
11-Digit Billing Format
60505437803
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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: 1738804 - PAXIL CR 12.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1738804 - 24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet [Paxil]

Clinical Specifications

Proprietary Name
Paxil CR
Non-Proprietary Name
Paroxetine Hydrochloride
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
Paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Paroxetine is known as a selective serotonin reuptake inhibitor (SSRI). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand washing, counting, and checking) that interfere with daily living.

Regulatory & Marketing

Labeler Name
Apotex Corp
Product Type
Human Prescription Drug
FDA Application #
NDA020936
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2011
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60505-4378-3 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Paxil CR, a human prescription drug labeled by Apotex Corp. 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 Apotex Corp on January 01, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Paroxetine is known as a selective serotonin reuptake inhibitor (SSRI). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand washing, counting, and checking) that interfere with daily living.

How is this Apotex Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505437803. 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 (5-4-1)
60505-4378-3
11-Digit CMS (5-4-2)
60505-4378-03

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