Methylphenidate Extended Release Oral Presentations Shortage

• • 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
  • 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, 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, 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 - discontinued
  • Methylphenidate CD extended release capsule, Teva, 20 mg, 100 count, NDC 00093-5296-01 - discontinued
  • Methylphenidate CD extended release capsule, Teva, 30 mg, 100 count, NDC 00093-5297-01 - discontinued
  • 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, Sandoz, 10 mg, 100 count, NDC 00781-2383-01
  • Methylphenidate LA extended release capsule, Sandoz, 20 mg, 100 count, NDC 00781-2384-01
  • Methylphenidate LA extended release capsule, Sandoz, 40 mg, 100 count, NDC 00781-2386-01
  • 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, 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, 30 mg, 90 count, NDC 00591-3873-19
  • Methylphenidate XR extended release capsule, Teva, 40 mg, 90 count, NDC 00591-3891-19
  • Methylphenidate XR extended release capsule, Teva, 60 mg, 90 count, NDC 00591-3902-19
  • 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 - discontinued
  • Ritalin LA extended release capsule, Sandoz, 20 mg, 100 count, NDC 00078-0370-05 - discontinued
  • Ritalin LA extended release capsule, Sandoz, 30 mg, 100 count, NDC 00078-0371-05 - discontinued
  • Ritalin LA extended release capsule, Sandoz, 40 mg, 100 count, NDC 00078-0372-05 - discontinued
  • Methylphenidate Hydrochloride extended release tablet, Dr. Reddy's, 18 mg, 100 count, NDC 43598-0438-01
  • Methylphenidate Hydrochloride extended release tablet, Dr. Reddy's, 27 mg, 100 count, NDC 43598-0439-01
  • Methylphenidate Hydrochloride extended release tablet, Dr. Reddy's, 54 mg, 100 count, NDC 43598-0441-01
  • 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, Mallinckrodt, 10 mg, 100 count, NDC 00406-1445-01
  • Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 20 mg, 100 count, NDC 00406-1473-01
  • Methylphenidate Hydrochloride extended release tablet, Mallinckrodt, 54 mg, 100 count, NDC 00406-0154-01
  • 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

• • Acella was not available to provide information.
  • Amneal did not provide a reason for the shortage.
  • Aytu BioPharma has Metadate CD extended-release 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 has all presentations available.
  • Ironhorse has Jornay PM available.
  • Janssen has Concerta extended-release tablets available.
  • KVK Tech has all marketed products available.
  • Lannett did not provide a reason for the shortage.
  • Mallinckrodt has methylphenidate extended-release products on shortage due to shortage of an active ingredient.
  • Rhodes did not provide a reason for the shortage of Aptensio XR and generic methylphenidate XR capsules.
  • Sandoz did not provide a reason for the shortage of methylphenidate extended-release (LA) capsules. The company recently updated NDC numbers. Sandoz discontinued Ritalin LA in mid-November 2024.
  • 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 10 mg, 20 mg, and 30 mg extended-release (CD) capsules in late-2024.
  • Trigen states the reason for the shortage is increased demand.
  • Tris Pharma has Quillichew ER chewable tablets and Quillivant XR liquid available.
  • Vertical states the reason for the shortage is increased demand.

• • 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
  • Metadate CD extended release capsule, Aytu BioPharma, 10 mg, 30 count, NDC 69654-0579-30
  • Metadate CD extended release capsule, Aytu BioPharma, 20 mg, 30 count, NDC 69654-0580-30
  • Metadate CD extended release capsule, Aytu BioPharma, 30 mg, 30 count, NDC 69654-0581-30
  • Metadate CD extended release capsule, Aytu BioPharma, 40 mg, 30 count, NDC 69654-0582-30
  • Metadate CD extended release capsule, Aytu BioPharma, 50 mg, 30 count, NDC 69654-0583-30
  • Metadate CD extended release capsule, Aytu BioPharma, 60 mg, 30 count, NDC 69654-0584-30
  • Methylphenidate CD extended release capsule, Amneal, 60 mg, 100 count, NDC 00115-1741-01
  • 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 LA extended release capsule, Sandoz, 30 mg, 100 count, NDC 00781-2363-01
  • 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, Teva, 20 mg, 90 count, NDC 00591-3869-19
  • Methylphenidate XR extended release capsule, Teva, 50 mg, 90 count, NDC 00591-3895-19
  • 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
  • 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, Dr. Reddy's, 36 mg, 100 count, NDC 43598-0440-01
  • Methylphenidate Hydrochloride extended release tablet, KVK-Tech, 10 mg, 100 count, NDC 10702-0075-01
  • Methylphenidate Hydrochloride extended release tablet, KVK-Tech, 20 mg, 100 count, NDC 10702-0076-01
  • 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, 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

• • Amneal has most methylphenidate extended-release (CD) capsules on back order and the company cannot estimate a release date.
  • Dr. Reddy's has methylphenidate 18 mg , 27 mg, and 54 mg extended-release tablets on back order and the company cannot estimate a release date.
  • Lannett has methylphenidate 18 mg, 27 mg, and 54 mg extended-release tablets on intermittent back order and the company is releasing supplies as they become available. The 36 mg extended-release tablets are on back order and the company cannot estimate a release date. Lannett has methylphenidate 10 mg and 50 mg extended-release (CD) capsules on back order and the company estimates a release date of early-June 2025. The 30 mg and 40 mg extended-release (CD) capsules are on back order and the company estimates a release date of mid-June 2025. The 20 mg extended-release (CD) capsules are on intermittent back order and the company is releasing supplies as they become available. The 60 mg extended-release (CD) capsules are on allocation.
  • Mallinckrodt has methylphenidate 54 mg extended-release tablets on allocation. Methylphenidate 10 mg extended-release tablets are also on allocation The 20 mg extended-release tablets are on back order and the company estimates a release date in early-May 2025.
  • Rhodes has all Aptensio XR capsules on back order and the company cannot estimate a release date. Methylphenidate 60 mg extended-release (XR) capsules are on back order and the company cannot estimate a release date.
  • Sandoz has methylphenidate 10 mg , 20 mg, and 40 mg extended-release (LA) capsules on allocation.
  • Teva has methylphenidate 18 mg, 27 mg, and 36 mg extended-release tablets on intermittent back order and the company is releasing supplies as they become available. The 54 mg extended-release tablets are on back order and the company estimates a release date of late-May 2025. The 20 mg, 30 mg, and 40 mg extended-release (LA) capsules are temporarily unavailable. The 10 mg, 15 mg, 30 mg, 40 mg, and 60 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.
  • Vertical has Relexxii tablets on allocation.

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