NDC 70165-003

Adzenys ER

Amphetamine

Adzenys ER is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics, Lp. The primary component is Amphetamine.

Product ID70165-003_4df2eebc-45bf-49a3-ae42-56b4c77905e5
NDC70165-003
Product TypeHuman Prescription Drug
Proprietary NameAdzenys ER
Generic NameAmphetamine
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-09-16
Marketing CategoryNDA / NDA
Application NumberNDA204325
Labeler NameNeos Therapeutics, LP
Substance NameAMPHETAMINE
Active Ingredient Strength1 mg/mL
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70165-003-15

450 mL in 1 BOTTLE, GLASS (70165-003-15)
Marketing Start Date2017-09-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70165-003-15 [70165000315]

Adzenys ER SUSPENSION, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA204325
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-16

Drug Details

Active Ingredients

IngredientStrength
AMPHETAMINE1.25 mg/mL

OpenFDA Data

SPL SET ID:eb1cc8d0-4231-41ea-8535-4fd872129713
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1945840
  • 1945844
  • Pharmacological Class

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

    Medicade Reported Pricing

    70165003030 ADZENYS XR-ODT 18.8 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Adzenys ER" or generic name "Amphetamine"

    NDCBrand NameGeneric Name
    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
    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

    Trademark Results [Adzenys ER]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADZENYS ER
    ADZENYS ER
    87599332 5628952 Live/Registered
    Neos Therapeutics, Inc.
    2017-09-07

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