LEQEMBI
These highlights do not include all the information needed to use LEQEMBI safely and effectively. See full prescribing information for LEQEMBI . LEQEMBI (lecanemab - irmb ) injection, for intravenous use Initial U.S. Approval: 2023
Approved
Approval ID
9d1ff786-e577-410a-a273-c4d7d0e4e975
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
Eisai Inc.
DUNS: 189246791
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lecanemab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-215
Application NumberBLA761269
Product Classification
M
Marketing Category
C73585
G
Generic Name
lecanemab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Quantity: 0.18 mg in 1 mL
Code: 4QD397987E
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 42.13 mg in 1 mL
Code: F7LTH1E20Y
Classification: IACT
LECANEMABActive
Quantity: 100 mg in 1 mL
Code: 12PYH0FTU9
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 4.99 mg in 1 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
lecanemab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-212
Application NumberBLA761269
Product Classification
M
Marketing Category
C73585
G
Generic Name
lecanemab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 26, 2023
FDA Product Classification
INGREDIENTS (6)
HISTIDINEInactive
Quantity: 0.18 mg in 1 mL
Code: 4QD397987E
Classification: IACT
LECANEMABActive
Quantity: 100 mg in 1 mL
Code: 12PYH0FTU9
Classification: ACTIB
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 4.99 mg in 1 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 42.13 mg in 1 mL
Code: F7LTH1E20Y
Classification: IACT