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1/10/2023

Methylphenidate Hydrochloride Extended Release Oral Presentations

Products Affected - Description

    • Methylphenidate CD extended release capsule, Amneal, 30 mg, 100 count, NDC 00115-1738-01
    • 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, 50 mg, 100 count, NDC 00527-4583-37
    • Methylphenidate CD extended release capsule, Lannett, 60 mg, 100 count, NDC 00527-4584-37
    • Methylphenidate CD extended release capsule, Teva, 10 mg, 100 count, NDC 00093-5295-01
    • 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, 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 Hydrochloride extended release tablet, Amneal, 18 mg, 90 count, NDC 65162-0231-09
    • Methylphenidate Hydrochloride extended release tablet, Amneal, 27 mg, 90 count, NDC 65162-0233-09
    • Methylphenidate Hydrochloride extended release tablet, Amneal, 36 mg, 90 count, NDC 65162-0235-09
    • Methylphenidate Hydrochloride extended release tablet, Amneal, 54 mg, 90 count, NDC 65162-0237-09
    • 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, 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, 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 did not provide a reason for the shortage.
    • Ani Pharmaceuticals was not available to provide information.
    • Camber has methylphenidate extended-release tablets on shortage pending DEA quota review.
    • Ironhorse has Jornay PM 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 is discontinuing 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 has extended-release tablets and capsules available.
    • Tris Pharma has Quillichew ER chewable tablets and Quillivant XR liquid available.
    • Vertical has Relexxii available.
    • XLCare has methylphenidate extended-release tablets on shortage due to reaching active ingredient DEA quota.

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
    • 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, 40 mg, 100 count, NDC 00527-4582-37
    • 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 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, 10 mg, 90 count, NDC 00591-3854-19
    • Methylphenidate XR extended release capsule, Teva, 40 mg, 90 count, NDC 00591-3891-19
    • 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, 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
    • 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
    • Methylphenidate Hydrochloride extended release tablet, Lannett, 18 mg, 100 count, NDC 62175-0310-37
    • 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

Estimated Resupply Dates

    • Camber has all methylphenidate extended-release tablets on back order and the company cannot estimate a release date.
    • Amneal has methylphenidate extended-release tablets on back order and the company cannot estimate a release date. Methylphenidate extended-release (CD) 30 mg capsules are also on back order and the company cannot estimate a release date.
    • Lannett has methylphenidate 27 mg and 36 mg extended-release tablets on back order and the company estimates a release date in early-March 2023. The 54 mg extended-release tablets are on back order and the company cannot estimate a release date. Lannett has methylphenidate extended-release (CD) 10 mg, 20 mg, 30 mg, and 50 mg capsules on back order and the company estimates release dates of early- to mid-January 2023 for the 10 mg capsules, mid-February 2023 for the 20 mg capsules, mid-March 2023 for the 30 mg capsules, and late-January to early-February 2023 for the 50 mg capsules. The 60 mg (CD) capsules are also 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 18 mg and 27 mg tablets on back order and the company estimates a release date of late-January 2023. The 36 mg and 54 mg tablets are also on back order and the company estimates a release date of early-February 2023 for the 36 mg tablets and early- to mid-February 2023 for the 54 mg tablets. Teva has the extended-release (CD) capsules on back order and the company estimates a release date in early-February 2023 for the 10 mg capsules and mid-January 2023 for the 40 mg, 50 mg, and 60 mg capsules. Teva has 15 mg, 20 mg, and 30 mg extended-release (XR) capsules on back order and the company estimates a release date in early-February 2022.
    • XLCare has methylphenidate extended-release tablets on back order and the company estimates a release date in January 2023.

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 January 10, 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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