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Acetylcysteine Oral and Inhalation Solution

Last Updated: June 1, 2020
Status: Current

Products Affected - Description
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 30 mL vial, 3 count, NDC 63323-0691-30
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 10 mL vial, 3 count, NDC 63323-0692-10
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 30 mL vial, 3 count, NDC 63323-0690-30
    • Acetylcysteine solution, Pfizer, 100 mg/mL, 30 mL vial, 3 count, NDC 00409-3307-03
Reason for the Shortage
    • American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. They are not currently marketing the 200 mg/mL 30 mL vials.
    • Arbor discontinued Cetylev effervescent tablets in April 2019.
    • Fresenius Kabi did not provide a reason for the shortage.
    • Pfizer has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
    • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
Available Products
    • Acetylcysteine solution, American Regent, 100 mg/mL, 4 mL vial, 25 count, NDC 00517-7504-25
    • Acetylcysteine solution, American Regent, 200 mg/mL, 4 mL vial, 3 count, NDC 00517-7604-25
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 10 mL vial, 3 count, NDC 63323-0693-10
    • Acetylcysteine solution, Fresenius Kabi, 100 mg/mL, 4 mL vial, 25 count, NDC 63323-0695-04
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 4 mL vial, 3 count, NDC 63323-0694-04
    • Acetylcysteine solution, Pfizer, 200 mg/mL, 30 mL vial, 3 count, NDC 00409-3308-03

Estimated Resupply Dates

    • Pfizer has acetylcysteine solution 100 mg/mL 30 mL vials available in limited supply.
    • Fresenius Kabi has acetylcysteine solution 200 mg/mL 10 mL and 30 mL vials on back order and the company estimates a release date of mid-June 2020 for the 10 mL vials and mid-July 2020 for the 30 mL vials. The 100 mg/mL 30 mL vials are on back order and the company estimates a release date of late-June 2020.

Updated

Updated June 1, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 28, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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