NDC 70165-030

Adzenys XR-ODT

Amphetamine

Adzenys XR-ODT is a Oral Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics Brands, Llc. The primary component is Amphetamine.

Product ID70165-030_c3cb48b4-d629-5c54-e053-2a95a90ab3d8
NDC70165-030
Product TypeHuman Prescription Drug
Proprietary NameAdzenys XR-ODT
Generic NameAmphetamine
Dosage FormTablet, Orally Disintegrating
Route of AdministrationORAL
Marketing Start Date2016-02-16
Marketing CategoryNDA / NDA
Application NumberNDA204326
Labeler NameNeos Therapeutics Brands, LLC
Substance NameAMPHETAMINE
Active Ingredient Strength19 mg/1
Pharm ClassesCentral Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70165-030-30

30 BLISTER PACK in 1 CARTON (70165-030-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date2016-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70165-030-30 [70165003030]

Adzenys XR-ODT TABLET, ORALLY DISINTEGRATING
Marketing CategoryNDA
Application NumberNDA204326
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-16

Drug Details

Active Ingredients

IngredientStrength
AMPHETAMINE18.8 mg/1

OpenFDA Data

SPL SET ID:c1179269-00b5-48ea-972d-31e614e99b7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1739839
  • 1739837
  • 1739803
  • 1739813
  • 1739815
  • 1739833
  • 1739825
  • 1739819
  • 1739809
  • 1739831
  • 1739821
  • 1739827
  • Pharmacological Class

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

    Medicade Reported Pricing

    70165030030 COTEMPLA XR-ODT 25.9 MG TABLET

    Pricing Unit: EA | Drug Type:

    70165003030 ADZENYS XR-ODT 18.8 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Adzenys XR-ODT" or generic name "Amphetamine"

    NDCBrand NameGeneric Name
    70165-005Adzenys XR-ODTAmphetamine
    70165-010Adzenys XR-ODTAmphetamine
    70165-025Adzenys XR-ODTAdzenys XR-ODT
    70165-020Adzenys XR-ODTAdzenys XR-ODT
    70165-030Adzenys XR-ODTAdzenys XR-ODT
    70165-015Adzenys XR-ODTAdzenys XR-ODT
    70165-003Adzenys ERAmphetamine
    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 XR-ODT]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADZENYS XR-ODT
    ADZENYS XR-ODT
    86847760 5147879 Live/Registered
    Neos Therapeutics, Inc.
    2015-12-14

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