FLUMAZENIL
FLUMAZENIL INJECTION, USP 0.5mg/5mL (0.1mg/mL) VIAL
Approved
Approval ID
74d007e9-9604-0941-e053-2a91aa0a29c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2024
Manufacturers
FDA
HF Acquisition Co. LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1254
Application NumberANDA078527
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUMAZENIL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 28, 2024
FDA Product Classification
INGREDIENTS (8)
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
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
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT