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Acetylcysteine Inhalation Solution

Last Updated: April 2, 2018
Status: Current

Acetylcysteine Oral and Inhalation Solution

Products Affected - Description
  • Acetylcysteine solution, American Regent

100 mg/mL, 4 mL vial, 25 count (NDC 00517-7504-25)
100 mg/mL, 10 mL vial, 3 count (NDC 00517-7510-03)
200 mg/mL, 4 mL vial, 3 count (NDC 00517-7604-25)
200 mg/mL, 10 mL vial, 3 count (NDC 00517-7610-03)
200 mg/mL, 30 mL vial, 3 count (NDC 00517-7630-03)
 
Acetylcysteine solution, Fresenius Kabi
100 mg/mL, 4 mL vial, 25 count (NDC 63323-0695-04)
100 mg/mL, 10 mL vial, 3 count (NDC 63323-0693-10)
100 mg/mL, 30 mL vial, 3 count (NDC 63323-0691-30)
200 mg/mL, 4 mL vial, 3 count (NDC 63323-0694-04)
200 mg/mL, 10 mL vial, 3 count (NDC 63323-0692-10)
 
Acetylcysteine solution, Pfizer
100 mg/mL, 30 mL vial, 3 count (NDC 00409-3307-03)
200 mg/mL, 30 mL vial, 3 count (NDC 00409-3308-03)
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 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, Fresenius Kabi
    200 mg/mL, 30 mL vial, 3 count (NDC 63323-0690-30)

Estimated Resupply Dates

    • American Regent has acetylcysteine solution 100 mg/mL 4 mL and 200 mg/mL 4 mL vials available in limited supply. The 100 mg/mL 10 mL and 200 mg/mL 10 mL and 30 mL vials are 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 early-April 2018. The 100 mg/mL 4 mL and 10 mL vials are on back order and the company estimates a release date of early-April 2018. The 100 mg/mL 30 mL vials are on back order and the company estimates a release date of mid-April 2018.
    • Pfizer has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company estimates a release date of mid-May 2018. The 100 mg/mL 30 mL vials are available in limited supply.

Updated

April 2, March 27 and 14, February 16, January 26, 22 and 11, 2018; December 18 and 5, November 17, October 2, August 15, June 5, March 13 and 2, February 13, January 27, 2017; November 29, October 17, September 6, August 16, May 2, April 11, February 24, January 12, 2016; December 3, November 16, October 15, September 4, July 16, June 8, May 15, April 10, March 23, January 16, 2015; December 3, October 23, August 18, June 6, May 27, April 11, March 10, February 7, 2014; December 27, November 5, October 18, September 16, July 17, June 14, May 24, April 17, February 27, January 21, 2013; December 31, November 28, October 22, September 25, August 23, July 10, June 5, May 22, April 11, March 9, January 18, 2012; December 14, November 8, October 4, September 7, August 26, June 28, 2011, University of Utah, Drug Information Service. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

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