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4/29/2020

Temazepam Capsules

Products Affected - Description

    • Temazepam capsule, Ascend, 15 mg, bottle, 500 count, NDC 67877-0146-05
    • Temazepam capsule, Ascend, 30 mg, bottle, 500 count, NDC 67877-0147-05
    • Temazepam capsule, Mylan, 15 mg, bottle, 90 count, NDC 00378-4010-77
    • Temazepam capsule, Mylan, 15 mg, bottle, 100 count, NDC 00378-4010-01
    • Temazepam capsule, Mylan, 15 mg, bottle, 500 count, NDC 00378-4010-05
    • Temazepam capsule, Mylan, 22.5 mg, bottle, 30 count, NDC 00378-3120-93
    • Temazepam capsule, Mylan, 30 mg, bottle, 90 count, NDC 00378-5050-77
    • Temazepam capsule, Mylan, 30 mg, bottle, 100 count, NDC 00378-5050-01
    • Temazepam capsule, Mylan, 30 mg, bottle, 500 count, NDC 00378-5050-05
    • Temazepam capsule, Mylan, 7.5 mg, bottle, 100 count, NDC 00378-3110-01
    • Temazepam capsule, Mylan Institutional, 15 mg, unit-dose blister pack, 100 count, NDC 51079-0418-20
    • Temazepam capsule, Mylan Institutional, 30 mg, unit-dose blister pack, 100 count, NDC 51079-0419-20
    • Temazepam capsule, Sun Pharma, 22.5 mg, bottle, 30 count, NDC 53489-0650-07 - discontinued
    • Temazepam capsule, Sun Pharma, 7.5 mg, bottle, 100 count, NDC 53489-0648-01 - discontinued
    • Temazepam capsule, Teva, 15 mg, bottle, 100 count, NDC 00228-2076-10
    • Temazepam capsule, Teva, 15 mg, bottle, 500 count, NDC 00228-2076-50
    • Temazepam capsule, Teva, 30 mg, bottle, 500 count, NDC 00228-2077-50

Reason for the Shortage

    • Ascend did not provide a reason for the shortage.
    • Major had temazepam on shortage due to manufacturing delays.
    • Mylan did not provide a reason for the shortage.
    • Sun Pharma discontinued temazepam capsules in 2019.
    • Teva did not provide a reason for the shortage.
    • Mallinckrodt has Restoril capsules available.
    • Mylan Institutional discontinued temazepam capsules in unit-dose packaging.

Available Products

    • Restoril capsule, Mallinckrodt, 15 mg, bottle, 100 count, NDC 00406-9916-01
    • Restoril capsule, Mallinckrodt, 22.5 mg, bottle, 30 count, NDC 00406-9914-03
    • Restoril capsule, Mallinckrodt, 30 mg, bottle, 100 count, NDC 00406-9917-01
    • Restoril capsule, Mallinckrodt, 7.5 mg, bottle, 30 count, NDC 00406-9915-03
    • Restoril capsule, Mallinckrodt, 7.5 mg, bottle, 100 count, NDC 00406-9915-01
    • Temazepam capsule, Ascend, 15 mg, bottle, 100 count, NDC 67877-0146-01
    • Temazepam capsule, Ascend, 22.5 mg, bottle, 30 count, NDC 67877-0149-30
    • Temazepam capsule, Ascend, 30 mg, bottle, 100 count, NDC 67877-0147-01
    • Temazepam capsule, Ascend, 7.5 mg, bottle, 100 count, NDC 67877-0148-01
    • Temazepam capsule, Major, 7.5 mg, bottle, 100 count, NDC 00904-6436-60
    • Temazepam capsule, Major, 7.5 mg, unit-dose blister pack, 30 count, NDC 00904-6436-04
    • Temazepam capsule, Teva, 30 mg, bottle, 100 count, NDC 00228-2077-10

Estimated Resupply Dates

    • Ascend has temazepam 15 mg and 30 mg capsules in 500 count bottles on intermittent back order and the company is releasing supplies as they become available.
    • Mylan has all presentations of temazepam capsules on back order and the company cannot estimate a release date.
    • Teva has temazepam 15 mg in 100 and 500 count and 30 mg in 500 count on intermittent back order and the company is releasing supplies as they become available.

Updated

Updated April 29, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created December 14, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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