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  4. NDC Product Code: 49884-842 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Er

NDC 49884-842 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Er

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Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49884-842?
  4. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
49884-842
Proprietary Name:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Er
Product Type: [3]
Labeler Name: [5]
Par Pharmaceutical, Inc.
Labeler Code:
49884
FDA Application Number: [6]
ANDA206159
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
06-25-2019
End Marketing Date: [10]
11-30-2023
Listing Expiration Date: [11]
11-30-2023
Exclude Flag: [12]
D
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Patient Education

Dextroamphetamine and Amphetamine


The combination of dextroamphetamine and amphetamine (Adderall, Adderall XR, Mydayis) is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Adderall is used to treat ADHD in adults and children 3 years of age and older. Adderall XR is used to treat ADHD in adults and children 6 years of age and older. Mydayis is used to treat ADHD in adults and children 13 years of age and older. Dextroamphetamine and amphetamine (Adderall) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep) in adults and children 12 years of age and older. The combination of dextroamphetamine and amphetamine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.
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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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".