NDC 27808-102

Dyanavel XR

Amphetamine

Dyanavel XR is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Tris Pharma Inc. The primary component is Amphetamine.

Product ID27808-102_853beb43-5e47-4336-b44b-b2b237df707c
NDC27808-102
Product TypeHuman Prescription Drug
Proprietary NameDyanavel XR
Generic NameAmphetamine
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-10-01
Marketing CategoryNDA / NDA
Application NumberNDA208147
Labeler NameTris Pharma Inc
Substance NameAMPHETAMINE
Active Ingredient Strength3 mg/mL
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 27808-102-01

464 mL in 1 BOTTLE (27808-102-01)
Marketing Start Date2015-10-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
AMPHETAMINE2.5 mg/mL

OpenFDA Data

SPL SET ID:a8a7eb93-4192-4826-bbf1-82c06634f553
Manufacturer:Tris Pharma Inc
UNII
RxNorm Concept Unique ID - RxCUI
  • 1720586
  • 1720592
  • Pharmacological Class

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

    Medicade Reported Pricing

    27808010201 DYANAVEL XR 2.5 MG/ML SUSP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Dyanavel XR" or generic name "Amphetamine"

    NDCBrand NameGeneric Name
    70165-003Adzenys ERAmphetamine
    70165-005Adzenys XR-ODTAmphetamine
    70165-010Adzenys XR-ODTAmphetamine
    70165-015Adzenys XR-ODTAmphetamine
    70165-020Adzenys XR-ODTAmphetamine
    70165-025Adzenys XR-ODTAmphetamine
    70165-030Adzenys XR-ODTAmphetamine
    66993-360Amphetamine Extended-Release Oral SuspensionAmphetamine
    69238-1563Amphetamine SulfateAmphetamine
    69238-1564Amphetamine SulfateAmphetamine
    69452-227Amphetamine SulfateAmphetamine
    69452-228Amphetamine SulfateAmphetamine
    27808-102Dyanavel XRamphetamine

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