Flumazenil
Flumazenil Injection, USP
Approved
Approval ID
19889fb5-7be1-4671-8c3b-e8168422283c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
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 Code70518-3456
Application NumberANDA076955
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUMAZENIL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 11, 2024
FDA Product Classification
INGREDIENTS (8)
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
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT