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11/7/2025

Methylphenidate Transdermal System

Products Affected - Description

    • Daytrana transdermal system, Noven, 10 mg/9 hours (1.1 mg/hr), patch, 30 count, NDC 68968-5552-03
    • Daytrana transdermal system, Noven, 15 mg/9 hours (1.6 mg/hr), patch, 30 count, NDC 68968-5553-03
    • Daytrana transdermal system, Noven, 20 mg/9 hours (2.2 mg/hr), patch, 30 count, NDC 68968-5554-03
    • Daytrana transdermal system, Noven, 30 mg/9 hours (3.3 mg/hr), patch, 30 count, NDC 68968-5555-03
    • Methylphenidate transdermal system, Padagis, 10 mg/9 hours (1.1 mg/hr), patch, 30 count, NDC 00574-2410-65
    • Methylphenidate transdermal system, Padagis, 15 mg/9 hours (1.6 mg/hr), patch, 30 count, NDC 00574-2415-65
    • Methylphenidate transdermal system, Padagis, 20 mg/9 hours (2.2 mg/hr), patch, 30 count, NDC 00574-2420-65
    • Methylphenidate transdermal system, Padagis, 30 mg/9 hours (3.3 mg/hr), patch, 30 count, NDC 00574-2430-65

Reason for the Shortage

    • Noven has Daytrana patches on back order due to a shortage of an active ingredient.
    • Mylan (Viatris) has methylphenidate patches available.
    • Padagis did not provide a reason for the shortage. Padagis is the distributor of the authorized generic.

Available Products

    • Methylphenidate transdermal system, Mylan (Viatris), 10 mg/9 hours (1.1 mg/hr), patch, 30 count, NDC 00378-8260-93
    • Methylphenidate transdermal system, Mylan (Viatris), 15 mg/9 hours (1.6 mg/hr), patch, 30 count, NDC 00378-8261-93
    • Methylphenidate transdermal system, Mylan (Viatris), 20 mg/9 hours (2.2 mg/hr), patch, 30 count, NDC 00378-8262-93
    • Methylphenidate transdermal system, Mylan (Viatris), 30 mg/9 hours (3.3 mg/hr), patch, 30 count, NDC 00378-8263-93

Estimated Resupply Dates

    • Noven has all Daytrana transdermal patches on back order and the company cannot estimate a release date.
    • Padagis has all methylphenidate transdermal patches on back order and the company cannot estimate a release date.

Implications for Patient Care

    • This drug is labeled for the treatment of attention-deficit/hyperactivity disorder in pediatric patients aged 6 to 17 years.[1-2]

Safety

    • Methylphenidate transdermal system is a schedule II controlled substance.[1-2]
    • Methylphenidate transdermal is not labeled for use in children less than 6 years of age due to increased exposure and higher number of reported adverse events.[1]
    • Misuse of and dependence on methylphenidate transdermal may occur. Adverse events when this drug is misused include but are not limited to increased respiratory rate, increased heart rate, coordination loss, gastrointestinal effects, and insomnia.[1]

Alternative Agents & Management

    • A stimulant medication is considered first-line therapy to treat attention-deficit/hyperactivity disorder in children aged 6 to 11 years old.[3-4]
    • Long-acting medications should be considered for adolescents, defined as 12 to 18 years. The guidance does not list one specific stimulant medication. Nonstimulant medications may be considered.[3-4]
    • Behavioral therapy may be considered in combination with medication therapy.[3-4]
    • Xelstrym® (dextroamphetamine) is an alternative stimulant agent available as a transdermal patch labeled to treat attention-deficit/hyperactivity disorder in pediatric patients aged 6 and older.[5]

References

    1. Daytrana (methylphenidate transdermal) [prescribing information]. Miami, FL: Noven Therapeutics LLC; September 2025.
    2. Methylphenidate. Lexicomp Online. Wolters Kluwer Clinical Drug Information. Hudson, Ohio, USA. Accessed October 22, 2025.
    3. Eom TH and Kim YH. Clinical practice guidelines for attention-deficit/hyperactivity disorder: recent updates. Clin Exp Pediatr 2023; 67: 26-34.
    4. Wolraich ML, Hagan JF, Allan C, et al. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics 2019. https://doi.org/10.1542/peds.2019-2528.
    5. Xelstrym (dextroamphetamine transdermal) [prescribing information]. Miami, FL: Noven Therapeutics LLC; October 2023.

Updated

Updated November 7, 2025 by Elyse MacDonald, PharmD, MS, BCPS. Created February 28, 2025 by Leslie Jensen, PharmD, Drug Information Specialist. © 2025, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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