NDC Package 60505-4851-3 Provigil

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
60505-4851-3
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Provigil
Non-Proprietary Name:
Provigil
Substance Name:
Modafinil
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.
11-Digit NDC Billing Format:
60505485103
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Apotex Corp
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
DEA Schedule:
Schedule IV (CIV) Substances
Sample Package:
No
FDA Application Number:
NDA020717
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
06-25-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
60505-4851-732000 TABLET, FILM COATED in 1 PAIL

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 60505-4851-3?

The NDC Packaged Code 60505-4851-3 is assigned to a package of 30 tablet, film coated in 1 bottle of Provigil, a human prescription drug labeled by Apotex Corp. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 60505-4851 included in the NDC Directory?

Yes, Provigil with product code 60505-4851 is active and included in the NDC Directory. The product was first marketed by Apotex Corp on June 25, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 60505-4851-3?

The 11-digit format is 60505485103. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-160505-4851-35-4-260505-4851-03