Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-release
NDC 57664-339

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57664-339?
  5. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-release Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-release is a ANDA-approved product labeled by Sun Pharmaceutical Industries, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a blue product. This product entry covers the primary NDC 57664-339 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
57664-339
Proprietary Name:
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-release
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Sun Pharmaceutical Industries, Inc.
Labeler Code:
57664
Product Label ID:
96f69fd0-dc4a-4455-971a-d4c40215e9d1
FDA Application Number: [6]
ANDA211715
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-05-2020
End Marketing Date: [10]
07-31-2024
Listing Expiration Date: [11]
07-31-2024
Exclude Flag: [12]
D

Product Characteristics

Color(s):
BLUE (C48333 - LIGHT)
BLUE (C48333 - POWDER)
WHITE (C48325)
ORANGE (C48331 - MEDIUM)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
18 MM
Imprint(s):
336;5;MG
337;10;MG
338;15;MG
339;20;MG
Score:
1

Code Structure Chart

Product Details

What is NDC 57664-339?

The NDC code 57664-339 is assigned by the FDA to the product Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-release. This pharmaceutical product is labeled by Sun Pharmaceutical Industries, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 57664-339-88. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules administration is contraindicated in patients with the following conditions:•Advanced arteriosclerosis•Symptomatic cardiovascular disease•Moderate to severe hypertension•Hyperthyroidism•In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2)]•Glaucoma•Agitated states•History of drug abuse•Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.6) and Drug Interactions (7.1)]

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

* Please review the full disclaimer at the bottom of this page.

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.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".