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5/19/2024

Dexmethylphenidate Extended Release Capsules

Products Affected - Description

    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 10 mg, bottle, 100 count, NDC 00115-9919-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 20 mg, bottle, 100 count, NDC 00115-9921-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 35 mg, bottle, 100 count, NDC 00115-1710-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 10 mg, bottle, 100 count, NDC 31722-0230-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 15 mg, bottle, 100 count, NDC 31722-0231-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 20 mg, bottle, 100 count, NDC 31722-0232-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 25 mg, bottle, 100 count, NDC 31722-0233-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 30 mg, bottle, 100 count, NDC 31722-0234-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 35 mg, bottle, 100 count, NDC 31722-0235-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 40 mg, bottle, 100 count, NDC 31722-0236-01 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Camber, 5 mg, bottle, 100 count, NDC 31722-0229-01 - discontinued
    • 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, 5 mg, bottle, 100 count, NDC 00527-8106-37
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 10 mg, bottle, 100 count, NDC 49884-0049-01
    • 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, 25 mg, bottle, 100 count, NDC 49884-0333-01
    • 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, Sun Pharma, 10 mg, bottle, 100 count, NDC 57664-0622-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 15 mg, bottle, 100 count, NDC 57664-0623-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 20 mg, bottle, 100 count, NDC 57664-0624-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 25 mg, bottle, 100 count, NDC 57664-0628-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 30 mg, bottle, 100 count, NDC 57664-0625-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 35 mg, bottle, 100 count, NDC 57664-0629-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 40 mg, bottle, 100 count, NDC 57664-0626-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Sun Pharma, 5 mg, bottle, 100 count, NDC 57664-0621-88 - discontinued
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 10 mg, bottle, 100 count, NDC 00093-5551-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 25 mg, bottle, 100 count, NDC 00093-5045-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 40 mg, bottle, 100 count, NDC 00093-5562-01

Reason for the Shortage

    • Amneal did not provide a reason for the shortage.
    • 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.
    • Sandoz has Focalin XR capsules available.
    • 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, 15 mg, bottle, 100 count, NDC 00078-0493-05
    • 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, 40 mg, bottle, 100 count, NDC 00078-0434-05
    • Focalin XR oral extended release capsule, Sandoz, 5 mg, bottle, 100 count, NDC 00078-0430-05
    • Dexmethylphenidate hydrochloride oral extended release capsule, Amneal, 15 mg, bottle, 100 count, NDC 00115-9920-01
    • 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, 5 mg, bottle, 100 count, NDC 00115-9918-01
    • 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, Par Pharmaceuticals, 20 mg, bottle, 100 count, NDC 49884-0248-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Par Pharmaceuticals, 30 mg, bottle, 100 count, NDC 49884-0430-01
    • 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, 30 mg, bottle, 100 count, NDC 00093-5554-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 35 mg, bottle, 100 count, NDC 00093-5046-01
    • Dexmethylphenidate hydrochloride oral extended release capsule, Teva, 5 mg, bottle, 100 count, NDC 00093-5550-01

Estimated Resupply Dates

    • Amneal has dexmethylphenidate 10 mg, 20 mg, and 35 mg extended-release capsules on intermittent back order and the company is releasing supplies as they become available.
    • Lannett has all dexmethylphenidate 5 mg, 10 mg, 15 mg, and 20 mg extended-release capsules on back order and the company cannot estimate a resupply date.
    • Par has dexmethylphenidate 5 mg, 10 mg, 15 mg, 25 mg, 35 mg, and 40 mg extended-release capsules on back order and the company cannot estimate a release date.
    • Teva has dexmethylphenidate 10 mg, 25 mg, and 40 mg extended-release capsules on intermittent back order and the company is releasing supplies as they become available.

Updated

Updated May 19, 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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