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7/8/2021

Sulfasalazine Enteric-Coated and Immediate-Release Tablets

Products Affected - Description

    • Sulfasalazine coated tablet, Greenstone, 500 mg, bottle, 100 count, NDC 59762-0104-05
    • Sulfasalazine coated tablet, Greenstone, 500 mg, bottle, 300 count, NDC 59762-0104-06
    • Azulfidine tablet, Pfizer, 500 mg, bottle, 100 count, NDC 00013-0101-10
    • Sulfasalazine tablet, Greenstone, 500 mg, bottle, 100 count, NDC 59762-5000-05
    • Sulfasalazine tablet, Greenstone, 500 mg, bottle, 300 count, NDC 59762-5000-06
    • Sulfasalazine tablet, Teva, 500 mg, bottle, 100 count, NDC 00591-0796-01
    • Sulfasalazine tablet, Teva, 500 mg, bottle, 500 count, NDC 00591-0796-05
    • Sulfasalazine tablet, Teva, 500 mg, bottle, 1000 count, NDC 00591-0796-10

Reason for the Shortage

    • Greenstone did not provide a reason for the shortage.
    • Teva did not provide a reason for the shortage.
    • Pfizer states the shortage is due to manufacturing delay. Azulfidine Entabs 500 mg in 300 count bottles have an updated NDC number.

Available Products

    • Azulfidine Entabs coated tablet, Pfizer, 500 mg, bottle, 100 count, NDC 00013-0102-50
    • Azulfidine Entabs coated tablet, Pfizer, 500 mg, bottle, 300 count, NDC 00013-0102-60
    • Azulfidine tablet, Pfizer, 500 mg, bottle, 300 count, NDC 00013-0101-20

Estimated Resupply Dates

    • Greenstone has sulfasalazine enteric-coated 500 mg tablets in 100 count and 300 count bottles on back order and the company estimates release dates in November 2021. The immediate-release 500 mg tablets in 100 and 300 count bottles are also on back order and the company estimates release dates in July 2021.
    • Pfizer has Azulfidine 500 mg tablets in 100 count bottles on back order and the company estimates a release date of late-October 2021.
    • Teva has sulfasalazine immediate-release 500 mg tablets on intermittent back order and the company is releasing supplies as they become available. They estimate an improvement in availability in mid-July 2021.

Updated

Updated July 8, 2021 by Anthony Trovato, PharmD, BCPS. Created January 8, 2020 by Rachael Freeman, PharmD, BCPS. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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