Human Drugs View

Product Information DR-XY47515_PI_01.pdf
Registration Number DR-XY47515
Generic Name Dexmedetomidine (as hydrochloride) in 0.9% w/v Sodium Chloride
Brand Name Precedex Premix
Dosage Strength 4 mcg/mL
Dosage Form Solution for Intravenous Infusion
Classification Prescription Drug (RX)
Pharmacologic Category Hypnotic/Sedative
Packaging 50 mL USP Type I clear and colorless glass bottle with gray bromobutyl rubber closure and aluminum light green flip-off seal (Box of 20 bottles in a tray); 100 mL USP Type I clear and colorless glass bottle with gray bromobutyl rubber closure and aluminum royal blue flip-off seal (Box of 10 bottles in a tray)
Manufacturer Hospira, Inc.
Country of Origin United States of America
Trader
Importer Pfizer, Inc.
Distributor
Application Type Monitored Release
Issuance Date 05 November 2021
Expiry Date 05 November 2026