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

• • All marketed presentations in production are available.

• • 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.