Manufacturing Establishments (1)
Medical Purchasing Solutions, LLC
Medical Purchasing Solutions, LLC
601458529
Products (1)
Flumazenil
71872-7038
ANDA078527
ANDA (C73584)
INTRAVENOUS
May 31, 2023
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.8 mg in 1 mL
FlumazenilActive
Code: 40P7XK9392Class: ACTIBQuantity: 0.1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.1 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.2 mg in 1 mL
Drug Labeling Information
INDICATIONS & USAGE SECTION
INDICATIONS AND USAGE
Adult Patients
Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (seePRECAUTIONS: Pediatric Use).