27808-109 : Dyanavel XR 15 mg Oral Tablet, Extended Release


NDC: 27808-109
Labeler: Tris Pharma Inc
Product Type: Human Prescription Drug
Drug Name:  Dyanavel XR
Dosage Form: Oral Tablet, Extended Release
Application #: NDA210526
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.

NDC Package Codes:

  • 27808-109-01: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE (27808‑109‑01)

Active Ingredients:

  • Amphetamine

Dosage Strength:

  • 15 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 27808-102 Dyanavel XR 2.5 mg/ml Oral Suspension, Extended Release by Tris Pharma Inc
  • 27808-106 Dyanavel XR 5 mg Oral Tablet, Extended Release by Tris Pharma Inc
  • 27808-108 Dyanavel XR 10 mg Oral Tablet, Extended Release by Tris Pharma Inc
  • 27808-110 Dyanavel XR 20 mg Oral Tablet, Extended Release by Tris Pharma Inc
  • 24478-102 Dyanavel XR 2.5 mg/ml Oral Suspension, Extended Release by Nextwave Pharmaceuticals, Inc
  • 24478-106 Dyanavel XR 5 mg Oral Tablet, Extended Release by Nextwave Pharmaceuticals, Inc
  • 24478-108 Dyanavel XR 10 mg Oral Tablet, Extended Release by Nextwave Pharmaceuticals, Inc
  • 24478-109 Dyanavel XR 15 mg Oral Tablet, Extended Release by Nextwave Pharmaceuticals, Inc
  • 24478-110 Dyanavel XR 20 mg Oral Tablet, Extended Release by Nextwave Pharmaceuticals, Inc

NDC QR Code

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NDC 27808-109 QR Code

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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.