FDA.reportPublic FDA data

Aduhelm

Product NDC
64406-101
11-digit product format
644060101
Labeler code
64406
Product ID
64406-101_59fdd1f8-3dac-4dce-aa56-c9801d443b40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aducanumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Biogen Inc.
Application
BLA761178
Marketing category
BLA
Marketing start
2021-06-07
Marketing end
0000-00-00
Substance
ADUCANUMAB
Active strength
100 mg/mL
Pharmacologic classes
Amyloid Beta-directed Antibody Interactions [MoA], Amyloid Beta-directed Antibody [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64406-101DDiscontinued by firm2026-07-31
excluded packagepackage64406-10164406-101-01DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64406-101-01ML - Milliliter64406-101f73a7c1a-d9c9-474b-bafa-00754378160312021-07-15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761178Aduhelmaducanumab-avwa351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64406-101-01644060101011 VIAL in 1 CARTON (64406-101-01) > 1.7 mL in 1 VIAL1 vial2021-06-070000-00-00NoNoCurrent