Provigil Tablet
NDC Package 63459-101-99

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

Provigil (modafinil) tablets is modafinil reduces extreme sleepiness due to narcolepsy and other sleep disorders, such as periods of stopped breathing during sleep (obstructive sleep apnea). This formulation utilizes a tablet delivery system. Marketed by Cephalon, Llc, this product is identified by NDC 63459-101 and is authorized under FDA application NDA020717.

Identification & Billing

NDC Package Code
63459-101-99
Package Description
40000 TABLET in 1 DRUM
Product Code
63459-101
11-Digit Billing Format
63459010199
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Provigil
Non-Proprietary Name
Modafinil
Substance Name
Modafinil
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Cephalon, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020717
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-15-1999
End Marketing Date
09-30-2026
Exclude Flag
N
Sample Package
N/A

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 (63459-101). Click a package code to view its specific billing and regulatory data.

63459-101-01
100 TABLET in 1 BOTTLE
63459-101-30
30 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 63459-101-99 identifies a specific commercial package of 40000 tablet in 1 drum of Provigil, a human prescription drug labeled by Cephalon, Llc. This tablet is formulated for oral use and contains modafinil 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 Cephalon, Llc on February 15, 1999.

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 Cephalon, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63459010199. 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)
63459-101-99
11-Digit CMS (5-4-2)
63459-0101-99

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