Forfivo
NDC Package 14350-450-01

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.

Forfivo is a medication used to treat depression. Marketed by Intelgenx Corp, this product is identified by NDC 14350-450 and is authorized under FDA application NDA022497.

Identification & Billing

NDC Package Code
14350-450-01
Package Description
450 TABLET, EXTENDED RELEASE in 1 BOTTLE, DISPENSING
Product Code
14350-450
11-Digit Billing Format
14350045001

Clinical Specifications

Proprietary Name
Forfivo XL
Dosage Form
-
Usage Information
This medication is used to treat depression. It may also be used to prevent seasonal affective disorder (SAD), a type of depression that occurs each year at the same time (for example, during winter). This medication can improve your mood and feelings of well-being. It may work by restoring the balance of certain natural substances (dopamine, norepinephrine) in the brain.

Regulatory & Marketing

Labeler Name
Intelgenx Corp
FDA Application #
NDA022497
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-29-2012
End Marketing Date
07-31-2012
Listing Expiration
07-31-2012
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 14350-450-01 identifies a specific commercial package of 450 tablet, extended release in 1 bottle, dispensing of Forfivo XL, labeled by Intelgenx Corp. 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 Intelgenx Corp on June 29, 2012. The current certification is valid through July 31, 2012.

What are the primary indications for this medication?

This medication is used to treat depression. It may also be used to prevent seasonal affective disorder (SAD), a type of depression that occurs each year at the same time (for example, during winter). This medication can improve your mood and feelings of well-being. It may work by restoring the balance of certain natural substances (dopamine, norepinephrine) in the brain.

How is this Intelgenx Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14350045001. 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)
14350-450-01
11-Digit CMS (5-4-2)
14350-0450-01

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