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9/23/2021

Labetalol Tablets

Products Affected - Description

    • Labetalol tablet, Alvogen, 100 mg, bottle, 100 count, NDC 47781-0552-01
    • Labetalol tablet, Alvogen, 100 mg, bottle, 500 count, NDC 47781-0552-05
    • Labetalol tablet, Alvogen, 200 mg, bottle, 100 count, NDC 47781-0553-01
    • Labetalol tablet, Alvogen, 200 mg, bottle, 500 count, NDC 47781-0553-05
    • Labetalol tablet, Alvogen, 300 mg, bottle, 100 count, NDC 47781-0554-01
    • Labetalol tablet, Sandoz, 100 mg, bottle, 100 count, NDC 00185-0010-01
    • Labetalol tablet, Sandoz, 100 mg, bottle, 500 count, NDC 00185-0010-05
    • Labetalol tablet, Sandoz, 200 mg, bottle, 100 count, NDC 00185-0117-01
    • Labetalol tablet, Sandoz, 200 mg, bottle, 500 count, NDC 00185-0117-05
    • Labetalol tablet, Sandoz, 300 mg, bottle, 100 count, NDC 00185-0118-01
    • Labetalol tablet, Sandoz, 300 mg, bottle, 500 count, NDC 00185-0118-05
    • Labetalol tablet, Teva, 100 mg, bottle, 100 count, NDC 00591-0605-01
    • Labetalol tablet, Teva, 100 mg, bottle, 500 count, NDC 00591-0605-05
    • Labetalol tablet, Teva, 200 mg, bottle, 100 count, NDC 00591-0606-01
    • Labetalol tablet, Teva, 300 mg, bottle, 100 count, NDC 00591-0607-01
    • Labetalol tablet, Zydus, 200 mg, bottle, 500 count, NDC 68382-0799-05

Reason for the Shortage

    • Alvogen has temporarily discontinued all presentations of labetalol tablets.
    • Major updated the NDC number for their labetalol tablet presentation.
    • Par has labetalol tablets available.
    • Sandoz did not provide a reason for the shortage.
    • Teva did not provide a reason for the shortage.
    • Zydus did not provide a reason for the shortage.

Available Products

    • Labetalol tablet, Major, 200 mg, unit-dose blister pack, 100 count, NDC 00904-7110-61
    • Labetalol tablet, Par Pharmaceuticals, 100 mg, bottle, 100 count, NDC 49884-0122-01
    • Labetalol tablet, Par Pharmaceuticals, 100 mg, bottle, 500 count, NDC 49884-0122-05
    • Labetalol tablet, Par Pharmaceuticals, 200 mg, bottle, 100 count, NDC 49884-0123-01
    • Labetalol tablet, Par Pharmaceuticals, 200 mg, bottle, 500 count, NDC 49884-0123-05
    • Labetalol tablet, Par Pharmaceuticals, 300 mg, bottle, 100 count, NDC 49884-0124-01
    • Labetalol tablet, Par Pharmaceuticals, 300 mg, bottle, 500 count, NDC 49884-0124-05
    • Labetalol tablet, Teva, 200 mg, bottle, 500 count, NDC 00591-0606-05
    • Labetalol tablet, Zydus, 100 mg, bottle, 100 count, NDC 68382-0798-01
    • Labetalol tablet, Zydus, 100 mg, bottle, 500 count, NDC 68382-0798-05
    • Labetalol tablet, Zydus, 200 mg, bottle, 100 count, NDC 68382-0799-01
    • Labetalol tablet, Zydus, 300 mg, bottle, 100 count, NDC 68382-0800-01
    • Labetalol tablet, Zydus, 300 mg, bottle, 500 count, NDC 68382-0800-05

Estimated Resupply Dates

    • Sandoz has all labetalol tablet presentations on back order and the company cannot estimate release dates.
    • Teva has labetalol 100 mg tablets in 100 and 500 count bottles on intermittent back order and the company is releasing supplies as they become available. The 200 mg tablets and 300 mg tablets in 100 count bottles are on back order and the company estimates a release date in late-September 2021 for the 200 mg tablets and late-October 2021 for the 300 mg tablets.
    • Zydus has labetalol 200 mg tablets in 500 count bottles on allocation.

Updated

Updated September 23, 2021 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 18, 2021 by Stephen Andrews, PharmD, BCPS, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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