Aduhelm
These highlights do not include all the information needed to use ADUHELM safely and effectively. See full prescribing information for ADUHELM. ADUHELM (aducanumab-avwa) injection, for intravenous use Initial U.S. Approval: 2021
Approved
Approval ID
41706573-546f-6774-6872-5374726f6e67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2023
Manufacturers
FDA
Biogen Inc.
DUNS: 121376230
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aducanumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-102
Application NumberBLA761178
Product Classification
M
Marketing Category
C73585
G
Generic Name
Aducanumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (7)
aducanumabActive
Quantity: 100 mg in 1 mL
Code: 105J35OE21
Classification: ACTIB
arginine hydrochlorideInactive
Quantity: 31.60 mg in 1 mL
Code: F7LTH1E20Y
Classification: IACT
histidineInactive
Quantity: 0.60 mg in 1 mL
Code: 4QD397987E
Classification: IACT
polysorbate 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
histidine monohydrochloride monohydrateInactive
Quantity: 3.39 mg in 1 mL
Code: X573657P6P
Classification: IACT
methionineInactive
Quantity: 1.49 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Aducanumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64406-101
Application NumberBLA761178
Product Classification
M
Marketing Category
C73585
G
Generic Name
Aducanumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 8, 2021
FDA Product Classification
INGREDIENTS (7)
aducanumabActive
Quantity: 100 mg in 1 mL
Code: 105J35OE21
Classification: ACTIB
arginine hydrochlorideInactive
Quantity: 31.60 mg in 1 mL
Code: F7LTH1E20Y
Classification: IACT
histidineInactive
Quantity: 0.60 mg in 1 mL
Code: 4QD397987E
Classification: IACT
histidine monohydrochloride monohydrateInactive
Quantity: 3.39 mg in 1 mL
Code: X573657P6P
Classification: IACT
methionineInactive
Quantity: 1.49 mg in 1 mL
Code: AE28F7PNPL
Classification: IACT
polysorbate 80Inactive
Quantity: 0.50 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT