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9/8/2024

Methylphenidate Immediate-Release Tablets

Products Affected - Description

    • Ritalin immediate release tablet, Sandoz, 10 mg, bottle, 100 count, NDC 00078-0440-05
    • Methylphenidate Hydrochloride immediate release tablet, Accord, 10 mg, bottle, 100 count, NDC 16729-0480-01
    • Methylphenidate Hydrochloride immediate release tablet, Accord, 10 mg, bottle, 100 count, NDC 16729-0479-01
    • Methylphenidate Hydrochloride immediate release tablet, Accord, 5 mg, bottle, 100 count, NDC 16729-0478-01
    • Methylphenidate Hydrochloride immediate release tablet, Camber, 10 mg, bottle, 100 count, NDC 31722-0174-01 - discontinued
    • Methylphenidate Hydrochloride immediate release tablet, Camber, 20 mg, bottle, 100 count, NDC 31722-0175-01 - discontinued
    • Methylphenidate Hydrochloride immediate release tablet, Camber, 5 mg, bottle, 100 count, NDC 31722-0173-01 - discontinued
    • Methylphenidate Hydrochloride immediate release tablet, KVK-Tech, 10 mg, bottle, 100 count, NDC 10702-0101-01
    • Methylphenidate Hydrochloride immediate release tablet, KVK-Tech, 20 mg, bottle, 100 count, NDC 10702-0102-01
    • Methylphenidate Hydrochloride immediate release tablet, KVK-Tech, 5 mg, bottle, 100 count, NDC 10702-0100-01
    • Methylphenidate Hydrochloride immediate release tablet, Solco Healthcare US, 10 mg, bottle, 100 count, NDC 43547-0487-10
    • Methylphenidate Hydrochloride immediate release tablet, Solco Healthcare US, 20 mg, bottle, 100 count, NDC 43547-0488-10
    • Methylphenidate Hydrochloride immediate release tablet, Solco Healthcare US, 5 mg, bottle, 100 count, NDC 43547-0486-10
    • Methylphenidate Hydrochloride immediate release tablet, Sun Pharma, 10 mg, bottle, 100 count, NDC 57664-0229-88
    • Methylphenidate Hydrochloride immediate release tablet, Sun Pharma, 5 mg, bottle, 100 count, NDC 57664-0228-88

Reason for the Shortage

    • Accord states the reason for the shortage is active ingredient delay.
    • Amneal has all marketed presentations available.
    • Camber discontinued methylphenidate immediate-release tablets.
    • KVK-Tech has methylphenidate immediate-release tablets on allocation due to meeting DEA quota.
    • Mallinckrodt refuses to provide availability information.
    • Novartis divested Ritalin tablets to Sandoz.
    • Sandoz did not provide a reason for the shortage.
    • Solco did not provide a reason for the shortage.
    • Sun Pharma has methylphenidate immediate-release tablets on shortage due to regulatory issues.
    • XLCare states the reason for the shortage is active ingredient delay.

Available Products

    • Ritalin immediate release tablet, Sandoz, 20 mg, bottle, 100 count, NDC 00078-0441-05
    • Ritalin immediate release tablet, Sandoz, 5 mg, bottle, 100 count, NDC 00078-0439-05
    • Methylphenidate Hydrochloride immediate release tablet, Amneal, 10 mg, bottle, 100 count, NDC 00115-1801-01
    • Methylphenidate Hydrochloride immediate release tablet, Amneal, 20 mg, bottle, 100 count, NDC 00115-1802-01
    • Methylphenidate Hydrochloride immediate release tablet, Amneal, 5 mg, bottle, 100 count, NDC 00115-1800-01
    • Methylphenidate Hydrochloride immediate release tablet, Sun Pharma, 20 mg, bottle, 100 count, NDC 57664-0230-88

Estimated Resupply Dates

    • Accord has all presentations on back order and the company cannot estimate a release date.
    • KVK-Tech has all presentations on allocation.
    • Sandoz has Ritalin 10 mg tablets on back order and the company cannot estimate a release date.
    • Solco has all presentations on allocation.
    • Sun Pharma has methylphenidate 5 mg and 10 mg immediate-release tablets on back order and the company cannot estimate a release date.

Safety

    • The CDC has issued a health advisory regarding potential disrupted access to prescription stimulant medications and possible increased risks for injury and overdose. The health advisory can be found at https://emergency.cdc.gov/han/2024/han00510.asp

Updated

Updated September 8, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created July 31, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. © 2024, 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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