0115-1704 : Dextroamphetamine Sulfateextended-release Extended-releaseextended-release 15 mg Oral Capsule, Extended Release


NDC0115-1704
Labeler: Impax Generics
Product Type: Human Prescription Drug
Drug Name: Dextroamphetamine Sulfateextended-release Extended-release
Dosage Form: Oral Capsule, Extended Release
Application #: NDA017078
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 329;CP;15mg
Shapes:  Capsule
Colors:  Red
Size (mm): 16
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 0115-1704-10: 90 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0115‑1704‑10)

Active Ingredients:

  • Dextroamphetamine Sulfate

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Cetyl Alcohol
  • D&c Yellow No. 10
  • Dibutyl Sebacate
  • Ethylcellulose (100 Mpa.s)
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Gelatin
  • Hypromelloses
  • Polyethylene Glycols
  • Povidone
  • Sodium Lauryl Sulfate

Pharmaceutical Classes:

  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]

Related Products:

Based on records with the same trade name.
  • 0115-1702 Dextroamphetamine Sulfateextended-release Extended-releaseextended-release 5 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1703 Dextroamphetamine Sulfateextended-release Extended-releaseextended-release 10 mg Oral Capsule, Extended Release by Impax Generics

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.