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8/15/2023

Methylphenidate Extended Release Oral Presentations

Products Affected - Description

    • 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, 30 mg, 100 count, NDC 00115-1738-01
    • 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, 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
    • Methylphenidate CD extended release capsule, Teva, 60 mg, 100 count, NDC 00093-5293-01
    • Methylphenidate CD extended release capsule, Teva, 50 mg 100 count, NDC 00093-5292-01
    • 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, 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
    • Relexxii extended release tablet, Vertical, 45 mg, 30 count, NDC 68025-0088-30
    • 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
    • Relexxii extended release tablet, Vertical, 72 mg, 100 count, NDC 68025-0084-10
    • 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, 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, Lannett, 54 mg, 100 count, NDC 62175-0313-37
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 18 mg, 100 count, NDC 57664-0606-88
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 27 mg, 100 count, NDC 57664-0607-88
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 36 mg, 100 count, NDC 57664-0608-88
    • Methylphenidate Hydrochloride extended release tablet, Sun Pharma, 54 mg, 100 count, NDC 57664-0609-88
    • 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 is not marketing the extended release tablets. The company did not provide a reason for the shortage of the extended-release (CD) capsules.
    • Aytu BioPharma has Cotempla XR-ODT extended-release oral disintegrating tablets available. Cotempla is dose equivalent to methylphenidate hydrochloride extended-release (CD) capsules.
    • Camber has methylphenidate extended-release tablets on shortage pending DEA quota review.
    • Ironhorse has Jornay PM available.
    • Janssen has Concerta extended-release tablets available.
    • KVK-Tech was not available to provide information
    • Lannett did not provide a reason for the shortage.
    • Mallinckrodt refuses to provide availability information.
    • Novartis has Ritalin LA capsules available.
    • Patriot discontinued methylphenidate extended-release tablets (authorized generic) in January 2023.
    • Rhodes has Aptensio XR capsules available.
    • Sandoz has methylphenidate LA extended-release capsules available.
    • Sun Pharma has methylphenidate extended-release tablets on shortage due to an active ingredient issue.
    • Teva did not provide a reason for the shortage. Teva has the extended-release (LA) capsules temporarily unavailable.
    • Trigen did not provide a reason for the shortage.
    • Tris Pharma has Quillichew ER chewable tablets and Quillivant XR liquid available.
    • Vertical did not provide a reason for the shortage.
    • 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, 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, 40 mg, 90 count, NDC 42858-0405-45
    • Aptensio XR extended release capsule, Rhodes, 50 mg, 90 count, NDC 42858-0406-45
    • Aptensio XR extended release capsule, Rhodes, 60 mg, 90 count, NDC 42858-0407-45
    • 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, 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, 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, 50 mg, 90 count, NDC 42858-0080-45
    • Methylphenidate XR extended release capsule, Rhodes, 60 mg, 90 count, NDC 42858-0081-45
    • 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
    • Ritalin LA extended release capsule, Novartis, 10 mg, 100 count, NDC 00078-0424-05
    • Ritalin LA extended release capsule, Novartis, 20 mg, 100 count, NDC 00078-0370-05
    • Ritalin LA extended release capsule, Novartis, 30 mg, 100 count, NDC 00078-0371-05
    • Ritalin LA extended release capsule, Novartis, 40 mg, 100 count, NDC 00078-0372-05

Estimated Resupply Dates

    • Amneal has methylphenidate extended-release (CD) capsules on back order and the company cannot estimate a release date.
    • Camber has all methylphenidate extended-release tablets on back order and the company cannot estimate a release date.
    • Lannett has methylphenidate 18 mg, 27 mg, 36 mg, and 54 mg extended-release tablets on back order and the company cannot estimate a release date.
    • Sun has all methylphenidate extended-release tablets on back order and the company cannot estimate a release date.
    • Teva has methylphenidate extended-release tablets on intermittent back order and the company is releasing supplies as they become available. Teva has the extended-release (CD) capsules on intermittent back order and the company is releasing supplies as they become available. The 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg extended-release (XR) capsules are also on intermittent back order and the company is releasing supplies as they become available. The 20 mg, 30 mg, and 40 mg extended-release (LA) capsules are temporarily unavailable.
    • Trigen has all methylphenidate extended-release tablets on allocation.
    • Vertical has all Relexxii tablets on back order and the company cannot estimate a release date.
    • 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

Updated

Updated August 15, 2023 by Leslie Jensen, PharmD, Drug Information Specialist. Created December 20, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2023, Drug Information Service, University of Utah, Salt Lake City, UT.

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