FLUMAZENIL
FLUMAZENIL INJECTION, USP 0.5mg PER 5mL (0.1mg PER mL) 5mL VIAL
Approved
Approval ID
c5da455f-3213-ab11-e053-2995a90a54ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2021
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 Code51662-1579
Application NumberANDA076955
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUMAZENIL
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 28, 2021
FDA Product Classification
INGREDIENTS (8)
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB
PROPYLPARABENInactive
Quantity: 0.2 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT