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Methylphenidate Hydrochloride

[10 October 2014]

Products Affected - Description

Extended-Release Presentations 
Ritalin LA, Novartis
10 mg capsules, 100 count (NDC 00078-0424-05)
40 mg capsules, 100 count (NDC 00078-0372-05)

Daytrana, Noven
30 mg patch, 30 count (NDC 68968-5555-30)

Methylphenidate Sustained-Release, Sandoz
20 mg tablets, 100 count (NDC 00781-5754-01)


Immediate Release Presentations
 
Methylphenidate, Mallinckrodt
5 mg tablets, 1000 count (NDC 00406-1142-10) - discontinued
10 mg tablets, 1000 count (NDC 00406-1144-10) - discontinued
20 mg tablets, 1000 count (NDC 00406-1146-10) - discontinued
 
Methylphenidate, Sandoz
5 mg tablets, 100 count (NDC 00781-5748-01)
20 mg tablets, 100 count (NDC 00781-5753-01)
 
Methylin chewable tablets, Shionogi Pharma
2.5 mg tablets, 100 count (NDC 59630-0760-10)
5 mg tablets, 100 count (NDC 59630-0761-10)
10 mg tablets, 100 count (NDC 59630-0762-10)

Reason for the Shortage

  • Mallinckrodt states the shortage was due to delay in obtaining raw materials. The company has stopped using the trade name Methylin and all products are now marketed as methylphenidate immediate-release or extended-release tablets with new NDC numbers.
  • Sandoz states that the shortage is due to delay in obtaining raw materials.
  • Teva introduced generic methylphenidate extended release capsules (CD) in late-September 2012, and these capsules are AB-rated to Metadate CD capsules.
  • UCB states methylphenidate IR tablets were on shortage due to supply and demand.
  • Actavis says the methylphenidate IR tablets were on shortage due to supply constraints.
  • Noven cannot provide a reason for the shortage of Daytrana patches.

Available Products

Extended-Release Presentations 
Methylphenidate ER, Actavis
20 mg capsules (NDC 67767-0200-01)
30 mg capsules (NDC 67767-0201-01)
40 mg capsules (NDC 67767-0202-01)
 
Metadate CD, UCB
10 mg capsules, 100 count (NDC 53014-0579-07)
20 mg capsules, 100 count (NDC 53014-0580-07)
30 mg capsules, 100 count (NDC 53014-0581-07)
40 mg capsules, 100 count (NDC 53014-0582-07)
50 mg capsules, 100 count (NDC 53014-0583-07)
60 mg capsules, 100 count (NDC 53014-0584-07)
 
Metadate ER, UCB
20 mg tablets, 100 count (NDC 53014-0594-07)
 
Methylphenidate ER, Mallinckrodt
10 mg tablets, 100 count (NDC 00406-1445-01)
20 mg tablets, 100 count (NDC 00406-1473-01)
 
Methylphenidate ER, Actavis
18 mg tablets, 100 count (NDC 00591-2715-01)
27 mg tablets, 100 count (NDC 00591-2716-01)
36 mg tablets, 100 count (NDC 00591-2717-01)
54 mg tablets, 100 count (NDC 00591-2718-01)
 
Methylphenidate CD, Teva
10 mg capsules, 100 count (NDC 00093-5295-01)
20 mg capsules, 100 count (NDC 00093-5296-01)
30 mg capsules, 100 count (NDC 00093-5297-01)
40 mg capsules, 100 count (NDC 00093-5298-01)
50 mg capsules, 100 count (NDC 00093-5292-01)
60 mg capsules, 100 count (NDC 00093-5293-01)

Ritalin LA, Novartis
20 mg capsules, 100 count (NDC 00078-0370-05)
30 mg capsules, 100 count (NDC 00078-0371-05)
 
Ritalin SR, Novartis
20 mg tablets, 100 count (NDC 00078-0442-05)
 
Concerta, Janssen-Ortho-McNeil
18 mg tablets, 100 count (NDC 50458-0585-01)
27 mg tablets, 100 count (NDC 50458-0588-01)
36 mg tablets, 100 count (NDC 50458-0586-01)
54 mg tablets, 100 count (NDC 50458-0587-01)

Daytrana, Noven
10 mg patch, 30 count (NDC 68968-5552-30)
15 mg patch, 30 count (NDC 68968-5553-30)
20 mg patch, 30 count (NDC 68968-5554-30)

Immediate-Release Presentations
Methylphenidate, Mallinckrodt
5 mg tablets, 100 count (NDC 00406-1142-01)
10 mg tablets, 100 count (NDC 00406-1144-01)
20 mg tablets, 100 count (NDC 00406-1146-01)  
 
Ritalin, Novartis
5 mg tablets, 100 count (NDC 00078-0439-05)
10 mg tablets, 100 count (NDC 00078-0440-05)
20 mg tablets, 100 count (NDC 00078-0441-05)
 
Methylphenidate, Actavis
5 mg tablets, 100 count (NDC 00591-5882-01)
10 mg tablets, 100 count (NDC 00591-5883-01)
20 mg tablets, 100 count (NDC 00591-5884-01)
 
Methylphenidate, UCB
5 mg tablets, 100 count (NDC 53014-0531-07)
10 mg tablets, 100 count (NDC 53014-0530-07)
20 mg tablets, 100 count (NDC 53014-0532-07)
 
Methylphenidate, Sandoz
10 mg tablets, 100 count (NDC 00781-5749-01)

Estimated Resupply Dates

Extended-Release Presentations
  • Novartis has Ritalin LA 10 mg and 40 mg capsules available in limited quantities.
  • Noven has Daytrana 30 mg patches available in limited quantities.
  • Sandoz has methylphenidate SR 20 mg tablets on back order and the company cannot estimate a release date.

Immediate-Release Presentations  

  • Sandoz has methylphenidate 5 mg tablets on back order and the company cannot estimate a release date. Methylphenidate 20 mg tablets are on back order and the company estimates a release date in late-October 2014.
  • Shionogi Pharma has all Methylin chewable tablets on back order and the company cannot estimate a release date. 

Related Shortages

Updated

October 10, 2014; September 24, 2014; September 10, 2014; August 15, 2014; June 23, 2014; June 5, 2014; April 15, 2014; March 27, 2014; February 27, 2014; February 11, 2014; January 17, 2014; November 14, 2013; October 17, 2013; September 23, 2013; August 28, 2013; August 13, 2013; July 29, 2013; June 20, 2013; June 7, 2013; May 22, 2013; May 15, 2013; April 5, 2013; March 8, 2013; February 22, 2013; January 24, 2013; November 30, 2012; November 2, 2012; October 1, 2012; September 12, 2012; July 18, 2012; June 25, 2012; May 17, 2012; April 23, 2012; March 8, 2012; February 17, 2012; January 30, 2012; January 13, 2012; December 14, 2011; October 19, 2011; October 6, 2011; September 21, 2011; August 3, 2011; July 6, 2011; June 23, 2011; June 6, 2011; May 19, 2011; May 13, 2011; May 5, 2011; April 8, 2011; March 23, 2011; March 8, 2011, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, 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, which 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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