Paroxetine Tablet, Film Coated
NDC Package 68071-2835-9

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

Package Information

Paroxetine (paroxetine hydrochloride hemihydrate) tablets is paroxetine tablets are indicated in adults for the treatment of:Major depressive disorder (MDD)Obsessive compulsive disorder (OCD)Panic disorder (PD)Social anxiety disorder (SAD)Generalized anxiety disorder (GAD)Posttraumatic stress disorder (PTSD). This formulation utilizes a tablet, film coated delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-2835 and is authorized under FDA application ANDA203854.

Identification & Billing

NDC Package Code
68071-2835-9
Package Description
90 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-2835
11-Digit Billing Format
68071283509
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paroxetine
Non-Proprietary Name
Paroxetine Hydrochloride Hemihydrate
Substance Name
Paroxetine Hydrochloride Hemihydrate
Dosage Form
Tablet, Film Coated - 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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 20 mg/1
Pharmacologic Class
Usage Information
Paroxetine tablets are indicated in adults for the treatment of:Major depressive disorder (MDD)Obsessive compulsive disorder (OCD)Panic disorder (PD)Social anxiety disorder (SAD)Generalized anxiety disorder (GAD)Posttraumatic stress disorder (PTSD)

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203854
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2022
Listing Expiration
12-31-2027
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 68071-2835-9 identifies a specific commercial package of 90 tablet, film coated in 1 bottle of Paroxetine, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains paroxetine hydrochloride hemihydrate 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 Nucare Pharmaceuticals, Inc. on March 29, 2022. The current certification is valid through December 31, 2027.

How is this Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071283509. 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)
68071-2835-9
11-Digit CMS (5-4-2)
68071-2835-09

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