Flumazenil
FLUMAZENIL INJECTION, USP
Approved
Approval ID
6671d89f-cc82-c03c-e053-2a91aa0aa5fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2022
Manufacturers
FDA
Medical Purchasing Solutions, LLC
DUNS: 601458529
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 Code71872-7008
Application NumberANDA078527
Product Classification
M
Marketing Category
C73584
G
Generic Name
flumazenil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (8)
METHYLPARABENInactive
Quantity: 1.8 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.1 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
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
FLUMAZENILActive
Quantity: 0.1 mg in 1 mL
Code: 40P7XK9392
Classification: ACTIB