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Flumazenil

FLUMAZENIL INJECTION, USP

Approved
Approval ID

6673efde-057a-a889-e053-2a91aa0a517b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 31, 2023

Manufacturers
FDA

Medical Purchasing Solutions, LLC

DUNS: 601458529

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

flumazenil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71872-7038
Application NumberANDA078527
Product Classification
M
Marketing Category
C73584
G
Generic Name
flumazenil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 31, 2023
FDA Product Classification

INGREDIENTS (8)

EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT

Drug Labeling Information

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/8/2013

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).

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Flumazenil - FDA Drug Approval Details