Brisdelle Capsule
NDC Package 83107-027-30

11-digit billing NDC: 83107002730
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Brisdelle (paroxetine) capsules is bRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.Limitations of Use:BRISDELLE is not indicated for the treatment of any psychiatric condition. This formulation utilizes a capsule delivery system. Marketed by Legacy Pharma Usa, Inc., this product is identified by NDC 83107-027 and is authorized under FDA application NDA204516.

Identification & Billing

NDC Package Code
83107-027-30
Package Description
30 CAPSULE in 1 BLISTER PACK
Product Code
83107-027
11-Digit Billing Format
83107002730
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Brisdelle
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
BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.Limitations of Use:BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE has a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower BRISDELLE dosage has not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing product that is indicated for such use.

Regulatory & Marketing

Labeler Name
Legacy Pharma Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204516
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-18-2025
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 83107-027-30 identifies a specific commercial package of 30 capsule in 1 blister pack of Brisdelle, a human prescription drug labeled by Legacy Pharma Usa, Inc.. 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 Legacy Pharma Usa, Inc. on February 18, 2025. The current certification is valid through December 31, 2026.

How is this Legacy Pharma Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83107002730. 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)
83107-027-30
11-Digit CMS (5-4-2)
83107-0027-30

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