Flumazenil
Flumazenil Injection, USP Rx only
Approved
Approval ID
17f3ea88-b403-4ee3-840a-640a0b9682b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2011
Manufacturers
FDA
West-ward Pharmaceutical Corp.
DUNS: 946499746
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 Code0641-6032
Application NumberANDA076787
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flumazenil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 28, 2011
FDA Product Classification
INGREDIENTS (9)
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
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Flumazenil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6031
Application NumberANDA076787
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flumazenil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 28, 2011
FDA Product Classification
INGREDIENTS (9)
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT