NDC 68968-5552

Daytrana

Methylphenidate

Daytrana is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Noven Therapeutics, Llc. The primary component is Methylphenidate.

Product ID68968-5552_21817861-4479-46b8-838d-4844a363a9b1
NDC68968-5552
Product TypeHuman Prescription Drug
Proprietary NameDaytrana
Generic NameMethylphenidate
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2006-04-06
Marketing CategoryNDA / NDA
Application NumberNDA021514
Labeler NameNoven Therapeutics, LLC
Substance NameMETHYLPHENIDATE
Active Ingredient Strength10 mg/9h
Pharm ClassesCentral Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68968-5552-3

30 PATCH in 1 CARTON (68968-5552-3) > 9 h in 1 PATCH
Marketing Start Date2006-04-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68968-5552-3 [68968555203]

Daytrana PATCH
Marketing CategoryNDA
Application NumberNDA021514
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-04-06

Drug Details

Active Ingredients

IngredientStrength
METHYLPHENIDATE10 mg/9h

OpenFDA Data

SPL SET ID:2c312c31-3198-4775-91ab-294e0b4b9e7f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 753443
  • 753442
  • 753438
  • 753439
  • 753436
  • 753437
  • 753441
  • 753440
  • Pharmacological Class

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

    Medicade Reported Pricing

    68968555203 DAYTRANA 10 MG/9 HR PATCH

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Daytrana" or generic name "Methylphenidate"

    NDCBrand NameGeneric Name
    68968-5552Daytranamethylphenidate
    68968-5553Daytranamethylphenidate
    68968-5554Daytranamethylphenidate
    68968-5555Daytranamethylphenidate
    70165-100Cotempla XR-ODTMethylphenidate
    0378-8260MethylphenidateMethylphenidate
    0378-8261MethylphenidateMethylphenidate
    0378-8262MethylphenidateMethylphenidate
    0378-8263MethylphenidateMethylphenidate
    0781-2361Methylphenidatemethylphenidate
    0781-2362Methylphenidatemethylphenidate
    0781-2363Methylphenidatemethylphenidate
    0781-2364Methylphenidatemethylphenidate

    Trademark Results [Daytrana]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DAYTRANA
    DAYTRANA
    78776854 3473825 Live/Registered
    NOVEN THERAPEUTICS, LLC
    2005-12-20
    DAYTRANA
    DAYTRANA
    78504631 not registered Dead/Abandoned
    Shire LLC
    2004-10-22

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