Paroxetine Capsule
NDC Package 43547-409-03

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

Package Information

Paroxetine capsules is a medication used to treat hot flashes that occur with menopause. This formulation utilizes a capsule delivery system. Marketed by Solco Healthcare Llc, this product is identified by NDC 43547-409 and is authorized under FDA application ANDA207188.

Identification & Billing

NDC Package Code
43547-409-03
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
43547-409
11-Digit Billing Format
43547040903
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Paroxetine
Non-Proprietary Name
Paroxetine
Substance Name
Paroxetine Mesylate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PAROXETINE MESYLATE 7.5 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat hot flashes that occur with menopause. Paroxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

Regulatory & Marketing

Labeler Name
Solco Healthcare Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207188
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2017
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 43547-409-03 identifies a specific commercial package of 30 capsule in 1 bottle of Paroxetine, a human prescription drug labeled by Solco Healthcare Llc. This capsule is formulated for oral use and contains paroxetine mesylate 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 Solco Healthcare Llc on August 15, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat hot flashes that occur with menopause. Paroxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

How is this Solco Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43547040903. 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)
43547-409-03
11-Digit CMS (5-4-2)
43547-0409-03

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