Armodafinil Tablet
NDC Package 72189-261-30

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

Package Information

Armodafinil tablets is armodafinil 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 Direct Rx, this product is identified by NDC 72189-261 and is authorized under FDA application NDA021875.

Identification & Billing

NDC Package Code
72189-261-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
72189-261
11-Digit Billing Format
72189026130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
RxCUI: 724861 - armodafinil 250 MG Oral Tablet

Clinical Specifications

Proprietary Name
Armodafinil
Non-Proprietary Name
Armodafinil
Substance Name
Armodafinil
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)
ARMODAFINIL 250 mg/1
Usage Information
Armodafinil 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. Armodafinil 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 armodafinil 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
Direct Rx
Product Type
Human Prescription Drug
FDA Application #
NDA021875
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-13-2021
Listing Expiration
12-31-2026
Exclude Flag
N
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 72189-261-30 identifies a specific commercial package of 30 tablet in 1 bottle of Armodafinil, a human prescription drug labeled by Direct Rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet is formulated for oral use and contains armodafinil 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 Direct Rx on September 13, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Armodafinil 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. Armodafinil 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 armodafinil 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 Direct Rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189026130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
72189-261-30
11-Digit CMS (5-4-2)
72189-0261-30

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