Modafinil
NDC Package 42291-600-30
Package Information
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 Avkare, this product is identified by NDC 42291-600 and is authorized under FDA application ANDA076715.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 42291 - Avkare
- 42291-600 - Modafinil
- 42291-600-30 - 30 TABLET in 1 BOTTLE
- 42291-600 - Modafinil
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 42291-600-30 identifies a specific commercial package of 30 tablet in 1 bottle of Modafinil, labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Avkare on April 03, 2013. The current certification is valid through February 28, 2019.
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 Avkare product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291060030. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.