1. Home
  2. Labeler Index
  3. Aurore Pharmaceuticals Private Limited
  4. NDC Product Code: 72761-023 Modafinil

NDC 72761-023 Modafinil

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 72761-023?
  4. Modafinil Uses
  5. Active Ingredients

Product 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.
NDC Product Code:
72761-023
Proprietary Name:
Modafinil
Non-Proprietary Name: [1]
Modafinil
Substance Name: [2]
Modafinil
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Aurore Pharmaceuticals Private Limited
Labeler Code:
72761
DEA Schedule: [7]
Schedule IV (CIV) Substances
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date: [9]
08-05-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Code Structure Chart

Product Details

What is NDC 72761-023?

The NDC code 72761-023 is assigned by the FDA to the UNFINISHED product Modafinil which is a bulk ingredient product labeled by Aurore Pharmaceuticals Private Limited. The generic name of Modafinil is modafinil. The product's dosage form is powder. The product is distributed in a single package with assigned NDC code 72761-023-06 50 kg in 1 drum . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Modafinil?

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.

What are Modafinil Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • MODAFINIL 1 kg/kg - A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[7] What is the Drug Enforcement Administration (DEA) CIV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.