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  4. NDC Product Code: 61919-770 Armodafinil

NDC 61919-770 Armodafinil

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 61919-770?
  5. Armodafinil Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
61919-770
Proprietary Name:
Armodafinil
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Direct_rx
Labeler Code:
61919
Product Label ID:
7ea5430a-df28-e521-e053-2a91aa0a8f22
Start Marketing Date: [9]
01-04-2019
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
LU;X43
Score:
1

Product Packages

NDC Code 61919-770-30

Package Description: 30 TABLET in 1 BOTTLE

Product Details

What is NDC 61919-770?

The NDC code 61919-770 is assigned by the FDA to the product Armodafinil which is product labeled by Direct_rx. The product's dosage form is . The product is distributed in a single package with assigned NDC code 61919-770-30 30 tablet in 1 bottle . 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 Armodafinil?

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.

Which are Armodafinil UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Armodafinil Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Armodafinil?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

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Patient Education

Armodafinil


Armodafinil is used to treat excessive sleepiness caused by narcolepsy (a condition that causes excessive daytime sleepiness) or shift work sleep disorder (sleepiness during scheduled waking hours and difficulty falling asleep or staying asleep during scheduled sleeping hours in people who work at night or on rotating shifts). Armodafinil is also used along with breathing devices or other treatments to prevent excessive sleepiness caused by obstructive sleep apnea/hypopnea syndrome (OSAHS; a sleep disorder in which the patient briefly stops breathing or breathes shallowly many times during sleep and therefore does not get enough restful sleep). Armodafinil is in a class of medications called wakefulness-promoting agents. It works by changing the amounts of certain natural substances in the area of the brain that controls sleep and wakefulness.
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Product Footnotes

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

[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".