Paroxetine Tablet, Film Coated, Extended Release
NDC Package 69367-337-30

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

Package Information

Paroxetine tablets is paroxetine extended-release tablets are indicated in adults for the treatment of:Major depressive disorder (MDD)Panic disorder (PD)Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Westminster Pharmaceuticals, Llc, this product is identified by NDC 69367-337 and is authorized under FDA application ANDA213485.

Identification & Billing

NDC Package Code
69367-337-30
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Product Code
69367-337
11-Digit Billing Format
69367033730
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: 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
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 37.5 mg/1
Pharmacologic Class
Usage Information
Paroxetine extended-release tablets are indicated in adults for the treatment of:Major depressive disorder (MDD)Panic disorder (PD)Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD)

Regulatory & Marketing

Labeler Name
Westminster Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213485
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2021
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 69367-337-30 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle, plastic of Paroxetine, a human prescription drug labeled by Westminster 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 Westminster Pharmaceuticals, Llc on July 26, 2021. The current certification is valid through December 31, 2026.

How is this Westminster Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69367033730. 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 (5-3-2)
69367-337-30
11-Digit CMS (5-4-2)
69367-0337-30

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