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_00548fef-2ddb-4860-9bd0-fc88e2ae759c
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 Through2021-12-31

Packaging

NDC 27808-102-01

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

NDC SPL Data Element Entries

NDC 27808-102-01 [27808010201]

Dyanavel XR SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208147
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-01

Drug Details

Active Ingredients

IngredientStrength
AMPHETAMINE2.5 mg/mL

OpenFDA Data

SPL SET ID:a8a7eb93-4192-4826-bbf1-82c06634f553
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1720586
  • 1720592
    • UPC Code
  • 0327808102010

    • 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
    24478-102Dyanavel XRamphetamine
    24478-106DYANAVEL XRamphetamine
    24478-108DYANAVEL XRamphetamine
    24478-109DYANAVEL XRamphetamine
    24478-110DYANAVEL XRamphetamine
    27808-102Dyanavel XRamphetamine
    27808-106DYANAVEL XRamphetamine
    27808-108DYANAVEL XRamphetamine
    27808-109DYANAVEL XRamphetamine
    27808-110DYANAVEL XRamphetamine
    70165-003Adzenys ERAmphetamine
    70165-005Adzenys XR-ODTAmphetamine
    70165-010Adzenys XR-ODTAmphetamine
    66993-360Amphetamine Extended-Release Oral SuspensionAmphetamine
    50742-652Amphetamine SulfateAmphetamine
    69238-1563Amphetamine SulfateAmphetamine
    69238-1564Amphetamine SulfateAmphetamine
    69452-227Amphetamine SulfateAmphetamine
    69452-228Amphetamine SulfateAmphetamine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.