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9/18/2020

Sertraline Oral Tablets

Products Affected - Description

    • Sertraline oral tablet, Accord, 100 mg, bottle, 500 count, NDC 16729-0217-16
    • Sertraline oral tablet, Accord, 50 mg, bottle, 500 count, NDC 16729-0216-16
    • Sertraline oral tablet, Cipla USA, 100 mg, bottle, 500 count, NDC 69097-0835-12
    • Sertraline oral tablet, Exelan Pharmaceuticals, 100 mg, bottle, 60 count, NDC 76282-0214-60
    • Sertraline oral tablet, Exelan Pharmaceuticals, 25 mg, bottle, 180 count, NDC 76282-0212-18
    • Sertraline oral tablet, Exelan Pharmaceuticals, 50 mg, bottle, 90 count, NDC 76282-0213-90
    • Sertraline oral tablet, Exelan Pharmaceuticals, 50 mg, bottle, 100 count, NDC 76282-0213-01
    • Sertraline oral tablet, Greenstone, 100 mg, bottle, 30 count, NDC 59762-5160-01
    • Sertraline oral tablet, Greenstone, 100 mg, bottle, 100 count, NDC 59762-5160-02
    • Sertraline oral tablet, Greenstone, 100 mg, bottle, 500 count, NDC 59762-5160-03
    • Sertraline oral tablet, Greenstone, 25 mg, bottle, 30 count, NDC 59762-6347-01
    • Sertraline oral tablet, Greenstone, 50 mg, bottle, 30 count, NDC 59762-6443-01
    • Sertraline oral tablet, Greenstone, 50 mg, bottle, 100 count, NDC 59762-6443-02
    • Sertraline oral tablet, Greenstone, 50 mg, bottle, 500 count, NDC 59762-6443-03
    • Sertraline oral tablet, Lupin, 100 mg, bottle, 30 count, NDC 68180-0353-06
    • Sertraline oral tablet, Lupin, 100 mg, bottle, 90 count, NDC 68180-0353-09
    • Sertraline oral tablet, Lupin, 100 mg, bottle, 500 count, NDC 68180-0353-02
    • Sertraline oral tablet, Lupin, 100 mg, bottle, 5000 count, NDC 68180-0353-05

Reason for the Shortage

    • Accord is unable to obtain active pharmaceutical ingredient to manufacture sertraline due to effects of COVID-19.
    • Aurobindo refuses to provide availability information.
    • Cipla USA did not provide a reason for the shortage.
    • Exelan Pharmaceuticals did not provide a reason for the shortage.
    • Greenstone did not provide a reason for the shortage.
    • Lupin has product on shortage due to increased demand and lack of supply of the active pharmaceutical ingredient.
    • Pfizer currently has enough product to supply historical demand.

Available Products

    • Zoloft oral tablet, Pfizer, 100 mg, bottle, 30 count, NDC 00049-4910-30
    • Zoloft oral tablet, Pfizer, 100 mg, unit-dose blister pack, 10 count, NDC 00049-4910-41
    • Zoloft oral tablet, Pfizer, 25 mg, bottle, 30 count, NDC 00049-4960-30
    • Zoloft oral tablet, Pfizer, 50 mg, bottle, 100 count, NDC 00049-4900-41
    • Zoloft oral tablet, Pfizer, 50 mg, unit-dose blister pack, 10 count, NDC 00049-4900-30
    • Sertraline oral tablet, Accord, 100 mg, bottle, 90 count, NDC 16729-0217-15
    • Sertraline oral tablet, Accord, 25 mg, bottle, 30 count, NDC 16729-0215-10
    • Sertraline oral tablet, Accord, 25 mg, bottle, 90 count, NDC 16729-0215-15
    • Sertraline oral tablet, Accord, 25 mg, bottle, 500 count, NDC 16729-0215-16
    • Sertraline oral tablet, Accord, 50 mg, bottle, 90 count, NDC 16729-0216-15
    • Sertraline oral tablet, Cipla USA, 100 mg, bottle, 30 count, NDC 69097-0835-02
    • Sertraline oral tablet, Cipla USA, 25 mg, bottle, 30 count, NDC 69097-0833-02
    • Sertraline oral tablet, Cipla USA, 25 mg, bottle, 90 count, NDC 69097-0833-05
    • Sertraline oral tablet, Cipla USA, 25 mg, bottle, 500 count, NDC 69097-0833-12
    • Sertraline oral tablet, Cipla USA, 50 mg, bottle, 30 count, NDC 69097-0834-02
    • Sertraline oral tablet, Cipla USA, 50 mg, bottle, 500 count, NDC 69097-0834-12
    • Sertraline oral tablet, Exelan Pharmaceuticals, 100 mg, bottle, 30 count, NDC 76282-0214-30
    • Sertraline oral tablet, Exelan Pharmaceuticals, 100 mg, bottle, 90 count, NDC 76282-0214-90
    • Sertraline oral tablet, Exelan Pharmaceuticals, 100 mg, bottle, 100 count, NDC 76282-0214-01
    • Sertraline oral tablet, Exelan Pharmaceuticals, 100 mg, bottle, 180 count, NDC 76282-0214-18
    • Sertraline oral tablet, Exelan Pharmaceuticals, 100 mg, bottle, 500 count, NDC 76282-0214-05
    • Sertraline oral tablet, Exelan Pharmaceuticals, 25 mg, bottle, 30 count, NDC 76282-0212-30
    • Sertraline oral tablet, Exelan Pharmaceuticals, 25 mg, bottle, 60 count, NDC 76282-0212-60
    • Sertraline oral tablet, Exelan Pharmaceuticals, 25 mg, bottle, 90 count, NDC 76282-0212-90
    • Sertraline oral tablet, Exelan Pharmaceuticals, 25 mg, bottle, 100 count, NDC 76282-0212-01
    • Sertraline oral tablet, Exelan Pharmaceuticals, 25 mg, bottle, 500 count, NDC 76282-0212-05
    • Sertraline oral tablet, Exelan Pharmaceuticals, 50 mg, bottle, 30 count, NDC 76282-0213-30
    • Sertraline oral tablet, Exelan Pharmaceuticals, 50 mg, bottle, 60 count, NDC 76282-0213-60
    • Sertraline oral tablet, Exelan Pharmaceuticals, 50 mg, bottle, 180 count, NDC 76282-0213-18
    • Sertraline oral tablet, Exelan Pharmaceuticals, 50 mg, bottle, 500 count, NDC 76282-0213-05
    • Sertraline oral tablet, Lupin, 25 mg, bottle, 30 count, NDC 68180-0351-06
    • Sertraline oral tablet, Lupin, 25 mg, bottle, 90 count, NDC 68180-0351-09
    • Sertraline oral tablet, Lupin, 25 mg, bottle, 1000 count, NDC 68180-0351-03
    • Sertraline oral tablet, Lupin, 50 mg, bottle, 30 count, NDC 68180-0352-06
    • Sertraline oral tablet, Lupin, 50 mg, bottle, 90 count, NDC 68180-0352-09
    • Sertraline oral tablet, Lupin, 50 mg, bottle, 500 count, NDC 68180-0352-02
    • Sertraline oral tablet, Lupin, 50 mg, bottle, 5000 count, NDC 68180-0352-05

Estimated Resupply Dates

    • Accord has sertraline 50 mg and 100 mg tablets in 500 count bottles on intermittent back order and the company is releasing supplies as they become available.
    • Cipla has sertraline 100 mg tablets in 500 count bottles on back order and the company cannot estimate a release date.
    • Exelan Pharmaceuticals has sertraline 25 mg tablets in 180 count bottles on back order and the company estimates a release date in October 2020. The 50 mg 90 count and 100 count bottles are on back order and the company cannot estimate a release date. The 100 mg tablets in 60 count bottles are on back order and the company estimates a release date in late-September 2020.
    • Greenstone has all sertraline tablet presentations on allocation.
    • Lupin has sertraline 100 mg tablets in 30, 90, 500, and 5,000 count bottles on intermittent back order and the company is releasing supplies as they become available.

Updated

Updated September 18, 2020 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 18, 2020 by Anthony Trovato, PharmD, BCPS. © 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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