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  5. NDC Package Code: 65862-601-81 Modafinil

NDC Package 65862-601-81 Modafinil

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
65862-601-81
Package Description:
8000 TABLET in 1 BAG
Product Code:
65862-601
Proprietary Name:
Modafinil
Non-Proprietary Name:
Modafinil
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:
65862060181
NDC to RxNorm Crosswalk:
  • RxCUI: 205324 - modafinil 200 MG Oral Tablet
  • RxCUI: 260218 - modafinil 100 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aurobindo Pharma Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MODAFINIL 100 mg/1
  • MODAFINIL 100 mg/1
    • Pharmacologic Class(es):
  • Central Nervous System Stimulation - [PE] (Physiologic Effect)
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
  • Sympathomimetic-like Agent - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    N/A
    FDA Application Number:
    ANDA202566
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-27-2012
    Listing Expiration Date:
    12-31-2024
    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
    65862-601-01100 TABLET in 1 BOTTLE
    65862-601-3030 TABLET in 1 BOTTLE
    65862-601-9090 TABLET in 1 BOTTLE
    65862-601-9290000 TABLET in 1 BAG
    65862-601-991000 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65862-601-81?

    The NDC Packaged Code 65862-601-81 is assigned to a package of 8000 tablet in 1 bag of Modafinil, a human prescription drug labeled by Aurobindo Pharma Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65862-601 included in the NDC Directory?

    Yes, Modafinil with product code 65862-601 is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on September 27, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-601-81?

    The 11-digit format is 65862060181. 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 5-3-2 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
    5-3-265862-601-815-4-265862-0601-81