57664-341 NDC - DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE EXTENDED-RELEASE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE)

Drug Information

  • Product NDC: 57664-341
  • Proprietary Name: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release
  • Non Proprietary Name: Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate
  • Active Ingredient(s): 7.5 mg/1 AMPHETAMINE ASPARTATE MONOHYDRATE; 7.5 mg/1 AMPHETAMINE SULFATE; 7.5 mg/1 DEXTROAMPHETAMINE SACCHARATE; 7.5 mg/1 DEXTROAMPHETAMINE SULFATE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE, EXTENDED RELEASE
  • Pharmacy Class(es): Central Nervous System Stimulant [EPC]; Central Nervous System Stimulant [EPC]; Central Nervous System Stimulant [EPC]; Central Nervous System Stimulant [EPC]; Central Nervous System Stimulation [PE]; Central Nervous System Stimulation [PE]; Central Nervous System Stimulation [PE]; Central Nervous System Stimulation [PE]

Labeler Information

Field Name Field Value
Labeler Name: Sun Pharmaceutical Industries, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA211715
Marketing Category: ANDA
Start Marketing Date:3/5/2020
DEA Schedule:CII

Package Information

No. Package Code Package Description Billing Unit
157664-341-88100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-341-88)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC57664-341The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-ReleaseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/5/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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.
APPLICATION NUMBERANDA211715This 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.
LABELER NAMESun Pharmaceutical Industries, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATEAn 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.
ACTIVE NUMERATOR STRENGTH7.5; 7.5; 7.5; 7.5 
ACTIVE INGRED UNITmg/1; mg/1; mg/1; mg/1 
PHARM CLASSESCentral Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE] 
DEA SCHEDULECIIThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 4/25/2025

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