Fresenius Kabi has announced the launch of Fentanyl Citrate Injection, USP 50mcg/mL in its proprietary Simplist® ready-to-administer prefilled syringe.

The new formulation is designed to support initiatives at hospitals nationwide to reduce waste and diversion. The Simplist ready-to-administer prefilled syringes require no assembly or point-of-care preparation. The product is supplied as 50mcg of fentanyl citrate per 1mL prefilled syringe and has a 24-month shelf life.

Fentanyl Citrate Injection is for intravenous (IV) or intramuscular (IM) use and should only be administered by persons specifically trained in IV anesthetics and management of respiratory effects in an adequate facility. It is indicated for:

  • Short-term analgesia during anesthetic periods, premedication, induction and maintenance and in the immediate postoperative periods as need arises. 
  • Use as an opioid analgesic supplement in general or regional anesthesia. 
  • Concomitant administration with a neuroleptic as an anesthetic premedication, for anesthesia induction and as an adjunct in the maintenance of general and regional anesthesia. 
  • Use as an anesthetic in combination with oxygen in selected high risk patients (eg, undergoing open heart surgery, complicated neurological or orthopedic procedures).

“The introduction of an exclusive smaller-dose fentanyl injection is an important expansion of our Simplist® ready-to-administer prefilled syringe portfolio in line with our commitment to the secure dispensing of controlled substances for the safe delivery of drugs to patients,” said John Ducker, president and CEO of Fresenius Kabi USA.


Fresenius Kabi introduces new Simplist® Fentanyl Citrate Injection, USP 50 mcg per 1 mL in ready-to-administer prefilled syringe. [press release]. Lake Zurich, IL: Fresenius Kabi; July 6, 2021.