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Dexmethylphenidate Hydrochloride

[22 October 2014]

Products Affected - Description

Immediate Release
Dexmethylphenidate immediate-release tablets, Teva
2.5 mg tablets, 100 count (NDC 00093-5275-01)
5 mg tablets, 100 count (NDC 00093-5276-01)
10 mg tablets, 100 count (NDC 00093-5277-01)

Dexmethylphenidate, extended release capsules, Teva
40 mg capsules, 100 count (NDC 00093-5562-01)

Reason for the Shortage

  • Teva has product on allocation and shortage is due to DEA quotas that are projected annually.
  • Mylan could not provide a reason for the shortage.
  • Novartis stated the reason for the shortage was increased demand.

Available Products

Immediate Release
Focalin tablets, Novartis
2.5 mg tablets, 100 count (NDC 00078-0380-05)
5 mg tablets, 100 count (NDC 00078-0381-05)
10 mg tablets, 100 count (NDC 00078-0382-05)

Extended Release
Dexmethylphenidate, extended release capsules, Mylan
30 mg capsules, 100 count (NDC 00378-4084-01)

Dexmethylphenidate, extended release capsules, Par
15 mg capsules, 100 count (NDC 49884-0428-01)
30 mg capsules, 100 count (NDC 49884-0430-01)

Dexmethylphenidate, extended release capsules, Sandoz
30 mg capsules, 100 count (NDC 00781-2687-01)
 
Focalin XR capsules, Novartis
5 mg capsules, 100 count (NDC 00078-0430-05)
10 mg capsules, 100 count (NDC 00078-0431-05)

15 mg capsules, 100 count (NDC 00078-0493-05)
20 mg capsules, 100 count (NDC 00078-0432-05)
25 mg capsules, 100 count (NDC 00078-0608-05)
30 mg capsules, 100 count (NDC 00078-0433-05)
35 mg capsules, 100 count (NDC 00078-0609-05)
40 mg capsules, 100 count (NDC 00078-0434-05)

Estimated Resupply Dates

Immediate Release

  • Teva has dexmethylphenidate 2.5 mg, 5 mg, and 10 mg tablets available and the products are being allocated.

Extended Release

  • Teva has dexmethylphenidate 40 mg extended-release capsules available and the product is being allocated.

Related Shortages

Updated

October 22, 2014; October 7, 2014; August 29, 2014; August 8, 2014; July 14, 2014; July 3, 2014; May 14, 2014; May 1, 2014; April 24, 2014; March 12, 2014; February 11, 2014, 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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