Flumazenil
Flumazenil Injection, USP
Approved
Approval ID
a72d9fc1-121c-455d-93a9-002378c9968f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-424
Application NumberANDA076955
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUMAZENIL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2017
FDA Product Classification
INGREDIENTS (8)
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT