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5/26/2016

Nicardipine Hydrochloride Injection

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.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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