Paroxetine Suspension
NDC Package 70954-319-10

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

Package Information

Paroxetine suspension is paroxetine is 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 suspension delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 70954-319 and is authorized under FDA application ANDA215003.

Identification & Billing

NDC Package Code
70954-319-10
Package Description
250 mL in 1 BOTTLE
Product Code
70954-319
11-Digit Billing Format
70954031910
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
250 ML
RxNorm Crosswalk
  • RxCUI: 312242 - PARoxetine HCl 10 MG in 5 mL Oral Suspension
  • RxCUI: 312242 - paroxetine hydrochloride 2 MG/ML Oral Suspension
  • RxCUI: 312242 - paroxetine (as paroxetine hydrochloride) 10 MG per 5 ML Oral Suspension

Clinical Specifications

Proprietary Name
Paroxetine
Non-Proprietary Name
Paroxetine
Substance Name
Paroxetine Hydrochloride Hemihydrate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PAROXETINE HYDROCHLORIDE HEMIHYDRATE 10 mg/5mL
Pharmacologic Class
Usage Information
Paroxetine is 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
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215003
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-03-2021
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 70954-319-10 identifies a specific commercial package of 250 ml in 1 bottle of Paroxetine, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. This suspension 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 Ani Pharmaceuticals, Inc. on September 03, 2021. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70954031910. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 250 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)
70954-319-10
11-Digit CMS (5-4-2)
70954-0319-10

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