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10/12/2024

Methylphenidate Extended Release Oral Presentations

Products Affected - Description

    • Aptensio XR extended release capsule, Rhodes, 10 mg, 90 count, NDC 42858-0401-45
    • Aptensio XR extended release capsule, Rhodes, 15 mg, 90 count, NDC 42858-0402-45
    • Aptensio XR extended release capsule, Rhodes, 20 mg, 90 count, NDC 42858-0403-45
    • Aptensio XR extended release capsule, Rhodes, 30 mg, 90 count, NDC 42858-0404-45
    • Aptensio XR extended release capsule, Rhodes, 60 mg, 90 count, NDC 42858-0407-45
    • Methylphenidate CD extended release capsule, Amneal, 30 mg, 100 count, NDC 00115-1738-01
    • Methylphenidate CD extended release capsule, Teva, 10 mg, 100 count, NDC 00093-5295-01
    • Methylphenidate CD extended release capsule, Teva, 20 mg, 100 count, NDC 00093-5296-01
    • Methylphenidate CD extended release capsule, Teva, 30 mg, 100 count, NDC 00093-5297-01
    • Methylphenidate CD extended release capsule, Teva, 40 mg, 100 count, NDC 00093-5298-01 - discontinued
    • Methylphenidate CD extended release capsule, Teva, 60 mg, 100 count, NDC 00093-5293-01 - discontinued
    • Methylphenidate CD extended release capsule, Teva, 50 mg 100 count, NDC 00093-5292-01 - discontinued
    • Methylphenidate LA extended release capsule, Teva, 20 mg, 100 count, NDC 00093-5346-01
    • Methylphenidate LA extended release capsule, Teva, 30 mg, 100 count, NDC 00093-5347-01
    • Methylphenidate LA extended release capsule, Teva, 40 mg, 100 count, NDC 00093-5348-01
    • Methylphenidate XR extended release capsule, Rhodes, 10 mg, 90 count, NDC 42858-0075-45
    • Methylphenidate XR extended release capsule, Rhodes, 15 mg, 90 count, NDC 42858-0076-45
    • Methylphenidate XR extended release capsule, Rhodes, 20 mg, 90 count, NDC 42858-0077-45
    • Methylphenidate XR extended release capsule, Rhodes, 30 mg, 90 count, NDC 42858-0078-45
    • Methylphenidate XR extended release capsule, Rhodes, 40 mg, 90 count, NDC 42858-0079-45
    • Methylphenidate XR extended release capsule, Rhodes, 60 mg, 90 count, NDC 42858-0081-45
    • Methylphenidate XR extended release capsule, Teva, 10 mg, 90 count, NDC 00591-3854-19
    • Methylphenidate XR extended release capsule, Teva, 15 mg, 90 count, NDC 00591-3862-19
    • Methylphenidate XR extended release capsule, Teva, 20 mg, 90 count, NDC 00591-3869-19
    • Methylphenidate XR extended release capsule, Teva, 30 mg, 90 count, NDC 00591-3873-19
    • Methylphenidate XR extended release capsule, Teva, 40 mg, 90 count, NDC 00591-3891-19
    • Methylphenidate Hydrochloride extended release tablet, Camber, 18 mg, 100 count, NDC 31722-0952-01
    • Methylphenidate Hydrochloride extended release tablet, Camber, 27 mg, 100 count, NDC 31722-0953-01
    • Methylphenidate Hydrochloride extended release tablet, Camber, 36 mg, 100 count, NDC 31722-0954-01
    • Methylphenidate Hydrochloride extended release tablet, Camber, 54 mg, 100 count, NDC 31722-0955-01
    • Methylphenidate Hydrochloride extended release tablet, Lannett, 54 mg, 100 count, NDC 62175-0313-37
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 18 mg, 100 count, NDC 57664-0606-88 - discontinued
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 27 mg, 100 count, NDC 57664-0607-88 - discontinued
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 36 mg, 100 count, NDC 57664-0608-88 - discontinued
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 54 mg, 100 count, NDC 57664-0609-88 - discontinued
    • Methylphenidate Hydrochloride extended release tablet, Teva, 18 mg, 100 count, NDC 62037-0725-01
    • Methylphenidate Hydrochloride extended release tablet, Teva, 27 mg, 100 count, NDC 62037-0734-01
    • Methylphenidate Hydrochloride extended release tablet, Teva, 36 mg, 100 count, NDC 62037-0726-01
    • Methylphenidate Hydrochloride extended release tablet, Teva, 54 mg, 100 count, NDC 62037-0727-01
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 18 mg, 100 count, NDC 13811-0706-10
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 27 mg, 100 count, NDC 13811-0707-10
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 36 mg, 100 count, NDC 13811-0708-10
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 54 mg, 100 count, NDC 13811-0709-10
    • Methylphenidate Hydrochloride extended release tablet, XLCare, 18 mg, 100 count, NDC 72865-0133-01
    • Methylphenidate Hydrochloride extended release tablet, XLCare, 27 mg, 100 count, NDC 72865-0134-01
    • Methylphenidate Hydrochloride extended release tablet, XLCare, 36 mg, 100 count, NDC 72865-0135-01
    • Methylphenidate Hydrochloride extended release tablet, XLCare, 54 mg, 100 count, NDC 72865-0136-01

Reason for the Shortage

    • Acella was not available to provide information.
    • Adlon discontinued Adhansia XR in July 2022.
    • Amneal discontinued the extended release tablets in March 2023. The company has the extended-release (CD) capsules available.
    • Aytu BioPharma has Cotempla XR-ODT extended-release oral disintegrating tablets available. Cotempla is dose equivalent to methylphenidate hydrochloride extended-release (CD) capsules.
    • Camber discontinued methylphenidate extended-release tablets.
    • Ironhorse has Jornay PM available.
    • Janssen has Concerta extended-release tablets available.
    • KVK-Tech was not available to provide information
    • Lannett has methylphenidate tablets available.
    • Mallinckrodt has all presentations available.
    • Patriot discontinued methylphenidate extended-release tablets (authorized generic) in January 2023.
    • Rhodes has Aptensio XR capsules available.
    • Sandoz has methylphenidate (LA) capsules and Ritalin LA capsules available.
    • Sun Pharma discontinued methylphenidate extended-release tablets.
    • Teva states the reason for the delay is manufacturing delay. Teva has the extended-release (LA) capsules temporarily unavailable. Teva discontinued the 40 mg, 50 mg, and 60 mg extended-release (CD) capsules in December 2023.
    • Trigen did not provide a reason for the shortage.
    • Tris Pharma has Quillichew ER chewable tablets and Quillivant XR liquid available.
    • Vertical has Relexxii tablets available.
    • XLCare has methylphenidate extended-release tablets on shortage because the company is awaiting DEA allocation for active ingredient.

Available Products

    • Aptensio XR extended release capsule, Rhodes, 40 mg, 90 count, NDC 42858-0405-45
    • Aptensio XR extended release capsule, Rhodes, 50 mg, 90 count, NDC 42858-0406-45
    • Concerta extended release tablet, Janssen, 18 mg, 100 count, NDC 50458-0585-01
    • Concerta extended release tablet, Janssen, 27 mg, 100 count, NDC 50458-0588-01
    • Concerta extended release tablet, Janssen, 36 mg, 100 count, NDC 50458-0586-01
    • Concerta extended release tablet, Janssen, 54 mg, 100 count, NDC 50458-0587-01
    • Cotempla XR-ODT oral disintegrating tablet, Aytu BioPharma, 17.3 mg, unit-dose blister pack, 30 count, NDC 70165-0200-30
    • Cotempla XR-ODT oral disintegrating tablet, Aytu BioPharma, 25.9 mg, unit-dose blister pack, 30 count, NDC 70165-0300-30
    • Cotempla XR-ODT oral disintegrating tablet, Aytu BioPharma, 8.6 mg, unit-dose blister pack, 30 count, NDC 70165-0100-30
    • Jornay PM extended release capsule, Ironhorse, 100 mg, 100 count, NDC 71376-0205-03
    • Jornay PM extended release capsule, Ironhorse, 20 mg, 100 count, NDC 71376-0201-03
    • Jornay PM extended release capsule, Ironhorse, 40 mg, 100 count, NDC 71376-0202-03
    • Jornay PM extended release capsule, Ironhorse, 60 mg, 100 count, NDC 71376-0203-03
    • Jornay PM extended release capsule, Ironhorse, 80 mg, 100 count, NDC 71376-0204-03
    • Methylphenidate CD extended release capsule, Amneal, 10 mg, 100 count, NDC 00115-1736-01
    • Methylphenidate CD extended release capsule, Amneal, 20 mg, 100 count, NDC 00115-1737-01
    • Methylphenidate CD extended release capsule, Amneal, 40 mg, 100 count, NDC 00115-1739-01
    • Methylphenidate CD extended release capsule, Amneal, 50 mg, 100 count, NDC 00115-1740-01
    • Methylphenidate CD extended release capsule, Amneal, 60 mg, 100 count, NDC 00115-1741-01
    • Methylphenidate CD extended release capsule, Lannett, 10 mg, 100 count, NDC 00527-4579-37
    • Methylphenidate CD extended release capsule, Lannett, 20 mg, 100 count, NDC 00527-4580-37
    • Methylphenidate CD extended release capsule, Lannett, 30 mg, 100 count, NDC 00527-4581-37
    • Methylphenidate CD extended release capsule, Lannett, 40 mg, 100 count, NDC 00527-4582-37
    • Methylphenidate CD extended release capsule, Lannett, 50 mg, 100 count, NDC 00527-4583-37
    • Methylphenidate CD extended release capsule, Lannett, 60 mg, 100 count, NDC 00527-4584-37
    • Methylphenidate LA extended release capsule, Mayne Pharma, 10 mg, 100 count, NDC 51862-0609-01
    • Methylphenidate LA extended release capsule, Mayne Pharma, 20 mg, 100 count, NDC 51862-0610-01
    • Methylphenidate LA extended release capsule, Mayne Pharma, 30 mg, 100 count, NDC 51862-0611-01
    • Methylphenidate LA extended release capsule, Mayne Pharma, 40 mg, 100 count, NDC 51862-0612-01
    • Methylphenidate LA extended release capsule, Mayne Pharma, 60 mg, 30 count, NDC 51862-0614-01
    • Methylphenidate LA extended release capsule, Sandoz, 10 mg, 100 count, NDC 00781-2361-01
    • Methylphenidate LA extended release capsule, Sandoz, 20 mg, 100 count, NDC 00781-2362-01
    • Methylphenidate LA extended release capsule, Sandoz, 30 mg, 100 count, NDC 00781-2363-01
    • Methylphenidate LA extended release capsule, Sandoz, 40 mg, 100 count, NDC 00781-2364-01
    • Methylphenidate XR extended release capsule, Rhodes, 50 mg, 90 count, NDC 42858-0080-45
    • Methylphenidate XR extended release capsule, Teva, 50 mg, 90 count, NDC 00591-3895-19
    • Methylphenidate XR extended release capsule, Teva, 60 mg, 90 count, NDC 00591-3902-19
    • QuilliChew ER extended-release chewable tablet, Tris Pharma, 20 mg, bottle, 100 count, NDC 24478-0074-01
    • QuilliChew ER extended-release chewable tablet, Tris Pharma, 30 mg, bottle, 100 count, NDC 24478-0075-01
    • QuilliChew ER extended-release chewable tablet, Tris Pharma, 40 mg, bottle, 100 count, NDC 24478-0076-01
    • Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 120 mL bottle, NDC 24478-0322-04
    • Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 150 mL bottle, NDC 24478-0323-05
    • Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 180 mL bottle, NDC 24478-0324-06
    • Quillivant XR extended-release oral powder for suspension, Tris Pharma, 5 mg/mL, 60 mL bottle, NDC 24478-0321-02
    • Relexxii extended release tablet, Vertical, 18 mg, 100 count, NDC 68025-0095-10
    • Relexxii extended release tablet, Vertical, 27 mg, 100 count, NDC 68025-0096-10
    • Relexxii extended release tablet, Vertical, 36 mg, 100 count, NDC 68025-0097-10
    • Relexxii extended release tablet, Vertical, 45 mg, 30 count, NDC 68025-0088-30
    • Relexxii extended release tablet, Vertical, 54 mg, 100 count, NDC 68025-0098-10
    • Relexxii extended release tablet, Vertical, 63 mg, 30 count, NDC 68025-0089-30
    • Relexxii extended release tablet, Vertical, 72 mg, 30 count, NDC 68025-0084-30
    • Ritalin LA extended release capsule, Sandoz, 10 mg, 100 count, NDC 00078-0424-05
    • Ritalin LA extended release capsule, Sandoz, 20 mg, 100 count, NDC 00078-0370-05
    • Ritalin LA extended release capsule, Sandoz, 30 mg, 100 count, NDC 00078-0371-05
    • Ritalin LA extended release capsule, Sandoz, 40 mg, 100 count, NDC 00078-0372-05
    • Methylphenidate Hydrochloride extended release tablet, Lannett, 18 mg, 100 count, NDC 62175-0310-37
    • Methylphenidate Hydrochloride extended release tablet, Lannett, 27 mg, 100 count, NDC 62175-0311-37
    • Methylphenidate Hydrochloride extended release tablet, Lannett, 36 mg, 100 count, NDC 62175-0312-37
    • Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 27 mg, 100 count, NDC 00406-0127-01
    • Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 36 mg, 100 count, NDC 00406-0136-01
    • Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 54 mg, 100 count, NDC 00406-0154-01
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 45 mg, 30 count, NDC 13811-0711-30
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 63 mg, 30 count, NDC 13811-0700-30
    • Methylphenidate Hydrochloride extended release tablet, Trigen, 72 mg, 30 count, NDC 13811-0710-30

Estimated Resupply Dates

    • Camber has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg XR capsules on allocation.
    • Rhodes has Aptensio XR 10 mg and 20 mg, capsules on back order and the company cannot estimate a release date. Aptensio XR 15 mg, 30 mg, and 60 mg capsules are available but with short dating (June 2025 for the 15 mg and 30 mg capsules and April 2025 for the 60 mg capsules). Generic methylphenidate 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 60 mg extended-release capsules on back order and the company cannot estimate a release date.
    • Teva has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg extended-release tablets on intermittent back order and the company is releasing supplies as they become available. Teva has 10 mg, 20 mg, and 30 mg extended-release (CD) capsules on back order and the company cannot estimate a release date. The 20 mg, 30 mg, and 40 mg extended-release (LA) capsules are temporarily unavailable. The 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg extended-release (XR) capsules are on intermittent back order and the company is releasing supplies as they become available.
    • Trigen has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg extended-release tablets on allocation.
    • XLCare has methylphenidate extended-release tablets on back order and the company cannot estimate a release date.

Implications for Patient Care

    • Lannett and Mallinckrodt extended-release tablets have a therapeutic equivalence rating of BX in FDA's Orange Book. The available data on these generic drug products are insufficient for FDA to determine therapeutic equivalence with Concerta

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 December 20, 2022 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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