edaravone
These highlights do not include all the information needed to use EDARAVONE INJECTION safely and effectively. See full prescribing information for EDARAVONE INJECTION. EDARAVONE injection, for intravenous use Initial U.S. Approval: 2017
Approved
Approval ID
a8245a98-2ccb-4062-b865-3aa348351b48
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2025
Manufacturers
FDA
XGen Pharmaceuticals DJB, Inc.
DUNS: 117380305
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
edaravone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-4500
Application NumberANDA217565
Product Classification
M
Marketing Category
C73584
G
Generic Name
edaravone
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 28, 2025
FDA Product Classification
INGREDIENTS (7)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BISULFITEInactive
Quantity: 20 mg in 100 mL
Code: TZX5469Z6I
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Quantity: 10 mg in 100 mL
Code: ZT934N0X4W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
EDARAVONEActive
Quantity: 30 mg in 100 mL
Code: S798V6YJRP
Classification: ACTIB
edaravone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code39822-4510
Application NumberANDA217565
Product Classification
M
Marketing Category
C73584
G
Generic Name
edaravone
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 28, 2025
FDA Product Classification
INGREDIENTS (7)
SODIUM BISULFITEInactive
Quantity: 40 mg in 100 mL
Code: TZX5469Z6I
Classification: IACT
CYSTEINE HYDROCHLORIDEInactive
Quantity: 20 mg in 100 mL
Code: ZT934N0X4W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDARAVONEActive
Quantity: 60 mg in 100 mL
Code: S798V6YJRP
Classification: ACTIB