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Nicardipine Hydrochloride Injection

Last Updated: May 26, 2016
Status: Resolved

Products Affected - Description
    • Cardene injection, Chiesi, 2.5 mg/mL, 10 mL ampule, 10 count, NDC 24477-0030-25
    • Nicardipine Hydrochloride injection, Sandoz, 2.5 mg/mL, 10 mL vial, 10 count, NDC 00781-3204-95
    • Nicardipine Hydrochloride injection, Sun Pharma, 2.5 mg/mL, 10 mL ampule, 10 count, NDC 41616-0882-44
Reason for the Shortage
    • American Regent has never started manufacturing nicardipine injection.
    • Caraco has temporarily discontinued nicardipine injection and it is unclear if product will return.
    • Chiesi acquired Cornerstone Therapeutics and changed the companies name in 2014. Cardene ampules were discontinued in March 2014. All premixed bags are available.
    • Mylan Institutional has had nicardipine injection temporarily unavailable since 2013 and it is unclear if product will return.
    • Sandoz has had nicardipine injection temporarily unavailable since 2013 and it is unclear if product will return.
    • West-Ward has nicardipine available.
    • Wockhardt has nicardipine on shortage due to an FDA import alert. It is unclear if product will return.
Available Products
    • Cardene injection, Chiesi, 20 mg/200 mL in 0.9% sodium chloride, premixed bag, 10 count, NDC 24477-0311-02
    • Cardene injection, Chiesi, 20 mg/200 mL in 5% dextrose, premixed bag, 10 count, NDC 24477-0312-02
    • Cardene injection, Chiesi, 40 mg/200 mL in 0.9% sodium chloride, premixed bag, NDC 24477-0323-02
    • Cardene injection, Chiesi, 40 mg/200 mL in 5% dextrose, premixed bag, 10 count, NDC 24477-0324-02
    • Nicardipine Hydrochloride injection, West-Ward, 2.5 mg/mL, 10 mL vial, 10 count, NDC 00143-9689-10

Estimated Resupply Dates

    • All marketed presentations in production are available.

Safety

    • West-Ward's nicardipine hydrochloride injection 2.5 mg/mL 10 mL vials contain benzoic acid and sodium chloride as excipients compared to other generic nicardipine 2.5 mg/mL 10 mL vials and ampules, which contain citric acid and sorbitol as excipients.

Updated

Updated May 26, 2016 by Leslie Jensen, PharmD, Drug Information Specialist. Created October 17, 2008 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, 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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