Modafinil Powder
NDC Package 82393-310-07

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Modafinil powders 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 powder delivery system. Marketed by Pharma Source Direct, Inc., this product is identified by NDC 82393-310.

Identification & Billing

NDC Package Code
82393-310-07
Package Description
.025 kg in 1 BOTTLE, PLASTIC
Product Code
82393-310
11-Digit Billing Format
82393031007
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
25.000 GM

Clinical Specifications

Proprietary Name
Modafinil
Non-Proprietary Name
Modafinil
Substance Name
Modafinil
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
MODAFINIL 1 kg/kg
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
Pharma Source Direct, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
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 (82393-310). Click a package code to view its specific billing and regulatory data.

82393-310-08
.1 kg in 1 BOTTLE, PLASTIC
82393-310-11
1 kg in 1 BOTTLE, PLASTIC

* 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 82393-310-07 identifies a specific commercial package of .025 kg in 1 bottle, plastic of Modafinil (UNFINISHED drug), a bulk ingredient labeled by Pharma Source Direct, Inc.. This product is billed per "GM" gram and contains an estimated amount of 25.000 billable units per package. This powder is formulated for 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 Pharma Source Direct, Inc. on November 01, 2023. The current certification is valid through December 31, 2026.

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 Pharma Source Direct, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82393031007. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 25.000 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 (5-3-2)
82393-310-07
11-Digit CMS (5-4-2)
82393-0310-07

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