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9/11/2019

Spironolactone Tablets

Products Affected - Description

    • Spironolactone oral tablet, Par Pharmaceuticals, 100 mg, bottle, 100 count, NDC 00603-5765-21 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 100 mg, bottle, 500 count, NDC 00603-5765-28 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 25 mg, bottle, 100 count, NDC 00603-5763-21 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 25 mg, bottle, 500 count, NDC 00603-5763-28 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 25 mg, bottle, 1000 count, NDC 00603-5763-32 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 25 mg, bottle, 2500 count, NDC 00603-5763-30 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 50 mg, bottle, 100 count, NDC 00603-5764-21 - discontinued
    • Spironolactone oral tablet, Par Pharmaceuticals, 50 mg, bottle, 500 count, NDC 00603-5764-28 - discontinued

Reason for the Shortage

    • Accord and Sun Pharma have spironolactone tablets available.
    • Amneal and Cadista have spironolactone tablets available.
    • Mylan refuses to provide updated availability information.
    • Par discontinued spironolactone tablets in August 2018.
    • Pfizer has Aldactone available.

Available Products

    • Aldactone oral tablet, Pfizer, 100 mg, bottle, 100 count, NDC 00025-1031-31
    • Aldactone oral tablet, Pfizer, 25 mg, bottle, 100 count, NDC 00025-1001-31
    • Aldactone oral tablet, Pfizer, 50 mg, bottle, 100 count, NDC 00025-1041-31
    • Spironolactone oral tablet, Accord, 100 mg, bottle, 100 count, NDC 16729-0227-01
    • Spironolactone oral tablet, Accord, 100 mg, bottle, 500 count, NDC 16729-0227-16
    • Spironolactone oral tablet, Accord, 25 mg, bottle, 100 count, NDC 16729-0225-01
    • Spironolactone oral tablet, Accord, 25 mg, bottle, 500 count, NDC 16729-0225-16
    • Spironolactone oral tablet, Accord, 25 mg, bottle, 1000 count, NDC 16729-0225-17
    • Spironolactone oral tablet, Accord, 50 mg, bottle, 100 count, NDC 16729-0226-01
    • Spironolactone oral tablet, Accord, 50 mg, bottle, 500 count, NDC 16729-0226-16
    • Spironolactone oral tablet, Amneal, 100 mg, bottle, 100 count, NDC 53746-0515-01
    • Spironolactone oral tablet, Amneal, 100 mg, bottle, 500 count, NDC 53746-0515-05
    • Spironolactone oral tablet, Amneal, 25 mg, bottle, 100 count, NDC 53746-0511-01
    • Spironolactone oral tablet, Amneal, 25 mg, bottle, 500 count, NDC 53746-0511-05
    • Spironolactone oral tablet, Amneal, 25 mg, bottle, 1000 count, NDC 53746-0511-10
    • Spironolactone oral tablet, Amneal, 50 mg, bottle, 100 count, NDC 53746-0514-01
    • Spironolactone oral tablet, Amneal, 50 mg, bottle, 500 count, NDC 53746-0514-05
    • Spironolactone oral tablet, Cadista, 100 mg, bottle, 100 count, NDC 59746-0218-01
    • Spironolactone oral tablet, Cadista, 25 mg, bottle, 100 count, NDC 59746-0216-01
    • Spironolactone oral tablet, Cadista, 25 mg, bottle, 500 count, NDC 59746-0216-05
    • Spironolactone oral tablet, Cadista, 50 mg, bottle, 100 count, NDC 59746-0217-01
    • Spironolactone oral tablet, Sun Pharma, 100 mg, bottle, 30 count, NDC 53489-0329-07
    • Spironolactone oral tablet, Sun Pharma, 100 mg, bottle, 60 count, NDC 53489-0329-06
    • Spironolactone oral tablet, Sun Pharma, 100 mg, bottle, 100 count, NDC 53489-0329-01
    • Spironolactone oral tablet, Sun Pharma, 100 mg, bottle, 500 count, NDC 53489-0329-05
    • Spironolactone oral tablet, Sun Pharma, 25 mg, bottle, 100 count, NDC 53489-0143-01
    • Spironolactone oral tablet, Sun Pharma, 25 mg, bottle, 500 count, NDC 53489-0143-05
    • Spironolactone oral tablet, Sun Pharma, 25 mg, bottle, 1000 count, NDC 53489-0143-10
    • Spironolactone oral tablet, Sun Pharma, 50 mg, bottle, 60 count, NDC 53489-0328-06
    • Spironolactone oral tablet, Sun Pharma, 50 mg, bottle, 100 count, NDC 53489-0328-01
    • Spironolactone oral tablet, Sun Pharma, 50 mg, bottle, 500 count, NDC 53489-0328-05

Estimated Resupply Dates

    • Accord, Amneal, Cadista, Pfizer, and Sun Pharma have product available.

Updated

Updated September 11, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. Created July 26, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, 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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