Flumazenil
FLUMAZENIL INJECTION, USP
Approved
Approval ID
436f5616-9626-4b6a-9deb-2986444179d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
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 Code0143-9684
Application NumberANDA078527
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flumazenil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (8)
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9.0 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Flumazenil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9683
Application NumberANDA078527
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flumazenil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (8)
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9.0 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT