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12/8/2022

Amoxicillin Oral Presentations

Products Affected - Description

    • Amoxicillin oral capsule, Hikma, 500 mg, bottle, 500 count, NDC 00143-9939-05
    • Amoxicillin oral powder for suspension, Hikma, 125 mg/5 mL, 100 mL bottle, NDC 00143-9888-01
    • Amoxicillin oral powder for suspension, Hikma, 125 mg/5 mL, 150 mL bottle, NDC 00143-9888-15
    • Amoxicillin oral powder for suspension, Hikma, 125 mg/5 mL, 80 mL bottle, NDC 00143-9888-80
    • Amoxicillin oral powder for suspension, Hikma, 200 mg/5 mL, 100 mL bottle, NDC 00143-9886-01
    • Amoxicillin oral powder for suspension, Hikma, 200 mg/5 mL, 50 mL bottle, NDC 00143-9886-50
    • Amoxicillin oral powder for suspension, Hikma, 200 mg/5 mL, 75 mL bottle, NDC 00143-9886-75
    • Amoxicillin oral powder for suspension, Hikma, 250 mg/5 mL, 100 mL bottle, NDC 00143-9889-01
    • Amoxicillin oral powder for suspension, Hikma, 250 mg/5 mL, 150 mL bottle, NDC 00143-9889-15
    • Amoxicillin oral powder for suspension, Hikma, 250 mg/5 mL, 80 mL bottle, NDC 00143-9889-80
    • Amoxicillin oral powder for suspension, Hikma, 400 mg/5 mL, 100 mL bottle, NDC 00143-9887-01
    • Amoxicillin oral powder for suspension, Hikma, 400 mg/5 mL, 50 mL bottle, NDC 00143-9887-50
    • Amoxicillin oral powder for suspension, Hikma, 400 mg/5 mL, 75 mL bottle, NDC 00143-9887-75
    • Amoxicillin tablet, Hikma, 875 mg, 100 count, NDC 00143-9285-01
    • Amoxicillin oral capsule, Sandoz, 250 mg, bottle, 100 count, NDC 00781-2020-01
    • Amoxicillin oral capsule, Sandoz, 250 mg, bottle, 500 count, NDC 00781-2020-05
    • Amoxicillin oral capsule, Sandoz, 500 mg, bottle, 100 count, NDC 00781-2613-01
    • Amoxicillin oral capsule, Sandoz, 500 mg, bottle, 500 count, NDC 00781-2613-05
    • Amoxicillin oral powder for suspension, Sandoz, 125 mg/5 mL, 100 mL bottle, 1 count, NDC 00781-6039-46
    • Amoxicillin oral powder for suspension, Sandoz, 125 mg/5 mL, 150 mL bottle, 1 count, NDC 00781-6039-55
    • Amoxicillin oral powder for suspension, Sandoz, 125 mg/5 mL, 80 mL bottle, 1 count, NDC 00781-6039-58
    • Amoxicillin oral powder for suspension, Sandoz, 200 mg/5 mL, 100 mL bottle, 1 count, NDC 00781-6156-46
    • Amoxicillin oral powder for suspension, Sandoz, 200 mg/5 mL, 50 mL bottle, 1 count, NDC 00781-6156-52
    • Amoxicillin oral powder for suspension, Sandoz, 200 mg/5 mL, 75 mL bottle, 1 count, NDC 00781-6156-57
    • Amoxicillin oral powder for suspension, Sandoz, 250 mg/5 mL, 100 mL bottle, 1 count, NDC 00781-6041-46
    • Amoxicillin oral powder for suspension, Sandoz, 250 mg/5 mL, 150 mL bottle, 1 count, NDC 00781-6041-55
    • Amoxicillin oral powder for suspension, Sandoz, 250 mg/5 mL, 80 mL bottle, 1 count, NDC 00781-6041-58
    • Amoxicillin oral powder for suspension, Sandoz, 400 mg/5 mL, 100 mL bottle, 1 count, NDC 00781-6157-46
    • Amoxicillin oral powder for suspension, Sandoz, 400 mg/5 mL, 50 mL bottle, 1 count, NDC 00781-6157-52
    • Amoxicillin oral powder for suspension, Sandoz, 400 mg/5 mL, 75 mL bottle, 1 count, NDC 00781-6157-57
    • Amoxicillin tablet, Sandoz, 875 mg, 20 count, NDC 00781-5061-20
    • Amoxicillin tablet, Sandoz, 875 mg, 100 count, NDC 00781-5061-01
    • Amoxicillin oral powder for suspension, Teva, 200 mg/5 mL, 100 mL bottle, 1 count, NDC 00093-4160-73
    • Amoxicillin oral powder for suspension, Teva, 200 mg/5 mL, 50 mL bottle, 1 count, NDC 00093-4160-76
    • Amoxicillin oral powder for suspension, Teva, 200 mg/5 mL, 75 mL bottle, 1 count, NDC 00093-4160-78
    • Amoxicillin oral powder for suspension, Teva, 250 mg/5 mL, 100 mL bottle, 1 count, NDC 00093-4155-73
    • Amoxicillin oral powder for suspension, Teva, 250 mg/5 mL, 150 mL bottle, 1 count, NDC 00093-4155-80
    • Amoxicillin oral powder for suspension, Teva, 250 mg/5 mL, 80 mL bottle, 1 count, NDC 00093-4155-79
    • Amoxicillin oral powder for suspension, Teva, 400 mg/5 mL, 100 mL bottle, 1 count, NDC 00093-4161-73
    • Amoxicillin oral powder for suspension, Teva, 400 mg/5 mL, 50 mL bottle, 1 count, NDC 00093-4161-76
    • Amoxicillin oral powder for suspension, Teva, 400 mg/5 mL, 75 mL bottle, 1 count, NDC 00093-4161-78
    • Amoxicillin chewable tablet, Teva, 125 mg, bottle, 100 count, NDC 00093-2267-01
    • Amoxicillin chewable tablet, Teva, 250 mg, bottle, 100 count, NDC 00093-2268-01
    • Amoxicillin tablet, Teva, 500 mg, 100 count, NDC 00093-2263-01

Reason for the Shortage

    • Aurobindo refuses to provide availability information.
    • Hikma did not provide a reason for the shortage.
    • Rising has amoxicillin capsules and tablets available.
    • Sandoz did not provide a reason for the shortage.
    • Teva did not provide a reason for the shortage.

Available Products

    • Amoxicillin oral capsule, Rising Pharmaceuticals, 250 mg, bottle, 100 count, NDC 57237-0030-01
    • Amoxicillin oral capsule, Rising Pharmaceuticals, 250 mg, bottle, 500 count, NDC 57237-0030-05
    • Amoxicillin oral capsule, Rising Pharmaceuticals, 500 mg, bottle, 100 count, NDC 57237-0031-01
    • Amoxicillin oral capsule, Rising Pharmaceuticals, 500 mg, bottle, 500 count, NDC 57237-0031-05
    • Amoxicillin oral tablet, Rising Pharmaceuticals, 500 mg, bottle, 100 count, NDC 57237-0028-01
    • Amoxicillin oral tablet, Rising Pharmaceuticals, 875 mg, bottle, 20 count, NDC 57237-0029-20
    • Amoxicillin capsule, Teva, 250 mg, bottle, 100 count, NDC 00093-3107-01
    • Amoxicillin capsule, Teva, 250 mg, bottle, 500 count, NDC 00093-3107-05
    • Amoxicillin capsule, Teva, 500 mg, bottle, 50 count, NDC 00093-3109-53
    • Amoxicillin capsule, Teva, 500 mg, bottle, 500 count, NDC 00093-3109-05
    • Amoxicillin tablet, Teva, 875 mg, 100 count, NDC 00093-2264-01

Estimated Resupply Dates

    • Hikma has all amoxicillin oral presentations on allocation. Amoxicillin 125 mg/5 mL in 80 mL bottles and 200 mg/5 mL in 50 mL bottles are short dated (August 2023). Amoxicillin 875 mg tablets in 20 count bottles are short dated (< August 2023).
    • Sandoz has amoxicillin 125 mg/5 mL 80 mL and 150 mL bottles available in limited supply. The 125 mg/5 mL 100 mL bottles are on back order and the company cannot estimate a release date. The 200 mg/5 mL 50 mL and 75 mL bottles are available in limited supply. The 200 mg/5 mL 100 mL bottles are on back order and the company cannot estimate a release date. The 250 mg/5 mL 80 mL and 150 mL bottles are on back order and the company cannot estimate a release date. The 250 mg/5 mL 100 mL bottles are available in limited supply. The 400 mg/5 mL 50 mL and 75 mL bottles are available in limited supply. The 400 mg/5 mL 100 mL bottles are on back order and the company cannot estimate a release date. The 875 mg tablets in 20 count are available in limited supply. The 875 mg tablets are on back order and the company cannot estimate a release date. The 250 mg capsules in 100 count and 500 count and 500 mg capsules in 100 count and 500 count are available in limited supply.
    • Teva has amoxicillin 200 mg/5 mL 50 mL, 75 mL, and 100 mL bottles and 250 mg/5 mL 80 mL bottles on intermittent back order and the company is releasing supplies as they become available. The 250 mg/5 mL 100 mL and 150 mL bottles are on back order and the company estimates a release date of mid-February 2022. The 400 mg/5 mL 50 mL, 75 mL, and 100 mL bottles are on back order and the company estimates a release date of mid-February 2023. The 125 mg chewable tablets are on back order and the company estimates a release date of early-February 2023. The 250 mg chewable tablets are on back order and the company estimates a release date of mid-January 2023.

Alternative Agents & Management

    • FDA has issued a guidance document regarding compounding certain beta-lactam products in shortage. This can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounding-certain-beta-lactam-products-shortage-under-section-503a-federal-food-drug-and-cosmetic?utm_medium=email&utm_source=govdelivery

Updated

Updated December 8, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 20, 2022 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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