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10/12/2024

Dexmethylphenidate Extended Release Capsules

Products Affected - Description

    • Focalin XR oral extended release capsule, Sandoz, 15 mg, bottle, 100 count, NDC 00078-0493-05
    • Focalin XR oral extended release capsule, Sandoz, 40 mg, bottle, 100 count, NDC 00078-0434-05
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 10 mg, bottle, 100 count, NDC 00527-8107-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 15 mg, bottle, 100 count, NDC 00527-8108-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 20 mg, bottle, 100 count, NDC 00527-8109-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 25 mg, bottle, 100 count, NDC 00527-8110-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 30 mg, bottle, 100 count, NDC 00527-8111-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 35 mg, bottle, 100 count, NDC 00527-8112-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 40 mg, bottle, 100 count, NDC 00527-8113-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Lannett, 5 mg, bottle, 100 count, NDC 00527-8106-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 15 mg, bottle, 100 count, NDC 49884-0428-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 20 mg, bottle, 100 count, NDC 49884-0248-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 25 mg, bottle, 100 count, NDC 49884-0333-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 30 mg, bottle, 100 count, NDC 49884-0430-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 35 mg, bottle, 100 count, NDC 49884-0339-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 40 mg, bottle, 100 count, NDC 49884-0546-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 5 mg, bottle, 100 count, NDC 49884-0048-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 10 mg, bottle, 100 count, NDC 00093-5551-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 15 mg, bottle, 100 count, NDC 00093-5552-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 20 mg, bottle, 100 count, NDC 00093-5553-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 25 mg, bottle, 100 count, NDC 00093-5045-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 30 mg, bottle, 100 count, NDC 00093-5554-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 40 mg, bottle, 100 count, NDC 00093-5562-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 5 mg, bottle, 100 count, NDC 00093-5550-01

Reason for the Shortage

    • Amneal has dexmethylphenidate extended-release capsules available.
    • Camber discontinued dexmethylphenidate extended-release capsules.
    • Lannett did not provide a reason for the shortage.
    • Novartis divested Focalin XR capsules to Sandoz.
    • Par did not provide a reason for the shortage. Par was not available to provide an update.
    • Sandoz did not provide a reason for the shortage.
    • Sun Pharma discontinued dexmethylphenidate extended-release capsules.
    • Teva did not provide a reason for the shortage.

Available Products

    • Focalin XR oral extended release capsule, Sandoz, 10 mg, bottle, 100 count, NDC 00078-0431-05
    • Focalin XR oral extended release capsule, Sandoz, 20 mg, bottle, 100 count, NDC 00078-0432-05
    • Focalin XR oral extended release capsule, Sandoz, 25 mg, bottle, 100 count, NDC 00078-0608-05
    • Focalin XR oral extended release capsule, Sandoz, 30 mg, bottle, 100 count, NDC 00078-0433-05
    • Focalin XR oral extended release capsule, Sandoz, 35 mg, bottle, 100 count, NDC 00078-0609-05
    • Focalin XR oral extended release capsule, Sandoz, 5 mg, bottle, 100 count, NDC 00078-0430-05
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 10 mg, bottle, 100 count, NDC 00115-9919-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 15 mg, bottle, 100 count, NDC 00115-9920-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 20 mg, bottle, 100 count, NDC 00115-9921-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 25 mg, bottle, 100 count, NDC 00115-1709-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 30 mg, bottle, 100 count, NDC 00115-9922-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 35 mg, bottle, 100 count, NDC 00115-1710-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 5 mg, bottle, 100 count, NDC 00115-9918-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 10 mg, bottle, 100 count, NDC 49884-0049-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 35 mg, bottle, 100 count, NDC 00093-5046-01

Estimated Resupply Dates

    • Lannett has all dexmethylphenidate extended-release products on allocation.
    • Par has dexmethylphenidate 5 mg and 25 mg extended-release capsules on back order and the company estimates a release date in late-September 2024. Dexmethylphenidate 15 mg, 20 mg, 30 mg, 35 mg, and 40 mg extended-release capsules are on back order and the company cannot estimate a release date.
    • Sandoz has Focalin XR 15 mg and 40 mg products on back order and the company estimates a release date in November 2024 for both products.
    • Teva has dexmethylphenidate 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, and 40 mg extended-release capsules on intermittent back order and the company is releasing product as it becomes available.

Safety

    • The CDC has issued a health advisory regarding potential disrupted access to care in patients taking 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 October 12, 2024 by Elyse MacDonald, PharmD, MS, BCPS. Created May 30, 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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