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5/16/2019

Theophylline 12-Hour Extended-Release Tablets

Products Affected - Description

    • Theophylline extended release tablet, Major, 100 mg, bottle, 100 count, NDC 00904-5887-61 - discontinued
    • Theophylline extended release tablet, Major, 200 mg, bottle, 100 count, NDC 00904-5888-61 - discontinued
    • Theophylline extended release tablet, Major, 300 mg, bottle, 100 count, NDC 00904-5889-61 - discontinued
    • Theophylline extended release tablet, Teva, 100 mg, bottle, 100 count, NDC 50111-0483-01
    • Theophylline extended release tablet, Teva, 100 mg, bottle, 500 count, NDC 50111-0483-02
    • Theophylline extended release tablet, Teva, 200 mg, bottle, 100 count, NDC 50111-0482-01
    • Theophylline extended release tablet, Teva, 200 mg, bottle, 500 count, NDC 50111-0482-02
    • Theophylline extended release tablet, Teva, 200 mg, bottle, 1000 count, NDC 50111-0482-03
    • Theophylline extended release tablet, Teva, 300 mg, bottle, 100 count, NDC 50111-0459-01
    • Theophylline extended release tablet, Teva, 300 mg, bottle, 500 count, NDC 50111-0459-02
    • Theophylline extended release tablet, Teva, 300 mg, bottle, 1000 count, NDC 50111-0459-03

Reason for the Shortage

    • Major has discontinued theophylline extended-release tablets.
    • Teva has had theophylline extended-release tablets temporarily unavailable for several years.
    • Theophylline 24-hour extended-release presentations are available from Mylan, Rhodes, and Endo Pharmaceuticals.

Available Products

    • Theophylline extended release tablet, Alembic, 300 mg, bottle, 100 count, NDC 62332-0025-31
    • Theophylline extended release tablet, Alembic, 450 mg, bottle, 100 count, NDC 62332-0026-31

Estimated Resupply Dates

    • Teva has theophylline extended-release tablets temporarily unavailable and the company cannot estimate a release date.

Updated

Updated May 16, 2019 by Megan Dryer, PharmD. Created December 16, 2015 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient 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. Vizient, 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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