Modafinil
NDC Package 0603-4662-29

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

Package Information

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

Modafinil is reduces extreme sleepiness due to narcolepsy and other sleep disorders, such as periods of stopped breathing during sleep (obstructive sleep apnea). Marketed by Qualitest Pharmaceuticals, this product is identified by NDC 0603-4662 and is authorized under FDA application ANDA202700.

Identification & Billing

NDC Package Code
0603-4662-29
Package Description
100 TABLET in 1 CARTON
Product Code
0603-4662
11-Digit Billing Format
00603466229

Clinical Specifications

Proprietary Name
Modafinil
Dosage Form
-
Usage Information
Modafinil reduces extreme sleepiness due to narcolepsy and other sleep disorders, such as periods of stopped breathing during sleep (obstructive sleep apnea). It is also used to help you stay awake during work hours if you have a work schedule that keeps you from having a normal sleep routine (shift work sleep disorder). This medication does not cure these sleep disorders and may not get rid of all your sleepiness. Modafinil does not take the place of getting enough sleep. It should not be used to treat tiredness or hold off sleep in people who do not have a sleep disorder. It is not known how modafinil works to keep you awake. It is thought to work by affecting certain substances in the brain that control the sleep/wake cycle.

Regulatory & Marketing

Labeler Name
Qualitest Pharmaceuticals
FDA Application #
ANDA202700
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-29-2013
End Marketing Date
06-30-2017
Listing Expiration
06-30-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0603-4662). Click a package code to view its specific billing and regulatory data.

0603-4662-02
90 TABLET in 1 BOTTLE
0603-4662-16
30 TABLET in 1 BOTTLE
0603-4662-20
60 TABLET in 1 BOTTLE
0603-4662-32
1000 TABLET in 1 BOTTLE

* 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 0603-4662-29 identifies a specific commercial package of 100 tablet in 1 carton of Modafinil, labeled by Qualitest Pharmaceuticals. 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 Qualitest Pharmaceuticals on January 29, 2013. The current certification is valid through June 30, 2017.

What are the primary indications for this medication?

Modafinil reduces extreme sleepiness due to narcolepsy and other sleep disorders, such as periods of stopped breathing during sleep (obstructive sleep apnea). It is also used to help you stay awake during work hours if you have a work schedule that keeps you from having a normal sleep routine (shift work sleep disorder). This medication does not cure these sleep disorders and may not get rid of all your sleepiness. Modafinil does not take the place of getting enough sleep. It should not be used to treat tiredness or hold off sleep in people who do not have a sleep disorder. It is not known how modafinil works to keep you awake. It is thought to work by affecting certain substances in the brain that control the sleep/wake cycle.

How is this Qualitest Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00603466229. 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 (4-4-2)
0603-4662-29
11-Digit CMS (5-4-2)
00603-4662-29

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