NDC 72912-535

ADHANSIA XR

Methylphenidate Hydrochloride

ADHANSIA XR is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Adlon Therapeutics L.p.. The primary component is Methylphenidate Hydrochloride.

Product ID72912-535_032a9e34-904e-b736-ba3a-59dbf8ba0f75
NDC72912-535
Product TypeHuman Prescription Drug
Proprietary NameADHANSIA XR
Generic NameMethylphenidate Hydrochloride
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-07-01
Marketing CategoryNDA / NDA
Application NumberNDA212038
Labeler NameAdlon Therapeutics L.P.
Substance NameMETHYLPHENIDATE HYDROCHLORIDE
Active Ingredient Strength35 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 72912-535-30

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72912-535-30)
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72912-535-30 [72912053530]

ADHANSIA XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212038
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-01

NDC 72912-535-10 [72912053510]

ADHANSIA XR CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA212038
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01
Marketing End Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE35 mg/1

OpenFDA Data

SPL SET ID:80e15bd0-4d56-75f0-ab5a-885879fc56e9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2119579
  • 2119569
  • 2119567
  • 2119575
  • 2119565
  • 2119577
  • 2119563
  • 2119571
  • 2119561
  • 2119573
  • 2119574
  • 2119559
    • UPC Code
  • 0372912570101
  • 0372912525101
  • 0372912585105
  • 0372912555108
  • 0372912535100
  • 0372912545109

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ADHANSIA XR" or generic name "Methylphenidate Hydrochloride"

    NDCBrand NameGeneric Name
    72912-535ADHANSIA XRADHANSIA XR
    72912-570ADHANSIA XRADHANSIA XR
    72912-555ADHANSIA XRADHANSIA XR
    72912-585ADHANSIA XRADHANSIA XR
    72912-525ADHANSIA XRADHANSIA XR
    72912-545ADHANSIA XRADHANSIA XR
    0093-3230Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3231Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0093-3232Methylphenidate Hydrochloride (LA)Methylphenidate Hydrochloride
    0078-0370Ritalinmethylphenidate hydrochloride
    0078-0371Ritalinmethylphenidate hydrochloride
    0078-0372Ritalinmethylphenidate hydrochloride
    0078-0424Ritalinmethylphenidate hydrochloride
    0078-0439Ritalinmethylphenidate hydrochloride
    0078-0440Ritalinmethylphenidate hydrochloride
    0078-0441Ritalinmethylphenidate hydrochloride

    Trademark Results [ADHANSIA XR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ADHANSIA XR
    ADHANSIA XR
    87982478 not registered Live/Pending
    PURDUE PHARMA L.P.
    2018-01-16
    ADHANSIA XR
    ADHANSIA XR
    87756623 not registered Live/Pending
    PURDUE PHARMA L.P.
    2018-01-16
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