Brisdelle
NDC Package 68968-9075-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Brisdelle is a medication used to treat hot flashes that occur with menopause. Marketed by Noven Therapeutics, Llc, this product is identified by NDC 68968-9075 and is authorized under FDA application NDA204516.

Identification & Billing

NDC Package Code
68968-9075-3
Package Description
30 CAPSULE in 1 BLISTER PACK
Product Code
68968-9075
11-Digit Billing Format
68968907503
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Brisdelle
Dosage Form
-
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
Noven Therapeutics, Llc
FDA Application #
NDA204516
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-28-2013
End Marketing Date
11-30-2017
Listing Expiration
11-30-2017
Exclude Flag
D
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 68968-9075-3 identifies a specific commercial package of 30 capsule in 1 blister pack of Brisdelle, labeled by Noven Therapeutics, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Noven Therapeutics, Llc on June 28, 2013. The current certification is valid through November 30, 2017.

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 Noven Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68968907503. 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 (5-4-1)
68968-9075-3
11-Digit CMS (5-4-2)
68968-9075-03

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