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Acetylcysteine Oral and Inhalation Solution

Last Updated: September 7, 2018
Status: Current

Products Affected - Description
    • Acetylcysteine solution, American Regent, 100 mg/mL, 10 mL vial, 3 count, NDC 00517-7510-03
    • Acetylcysteine solution, American Regent, 200 mg/mL, 10 mL vial, 3 count, NDC 00517-7610-03
    • Acetylcysteine solution, American Regent, 200 mg/mL, 30 mL vial, 3 count, NDC 00517-7630-03
    • 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, 10 mL vial, 3 count, NDC 63323-0692-10
    • Acetylcysteine solution, Fresenius Kabi, 200 mg/mL, 4 mL vial, 3 count, NDC 63323-0694-04
Reason for the Shortage
    • American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
    • Fresenius Kabi has acetylcysteine oral and inhalation solution available.
    • Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.
    • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.
    • Arbor has Cetylev effervescent tablets available. These are for oral use only.
Available Products
    • Cetylev oral effervescent tablet, Arbor, 2.5 gram, packet, 20 count, NDC 24338-0725-10
    • Cetylev oral effervescent tablet, Arbor, 500 mg, packet, 20 count, NDC 24338-0700-10
    • 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, 30 mL vial, 3 count, NDC 63323-0691-30
    • 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
    • Acetylcysteine solution, Pfizer, 200 mg/mL, 30 mL vial, 3 count, NDC 00409-3308-03

Estimated Resupply Dates

    • American Regent has acetylcysteine solution 100 mg/mL 10 mL and 200 mg/mL 10 mL and 30 mL vials on back order and the company cannot estimate a release date.
    • Fresenius Kabi has acetylcysteine solution 200 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of late-September 2018. The 100 mg/mL 4 mL and 10 mL vials are on back order and the company estimates a release date of late-September 2018.

Updated

Updated September 7, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 28, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2018, 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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