Aduhelm

Product NDC: 64406-101
Requested package NDC: 64406-101-01
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64406-101	64406-101-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64406-101-01	ML - Milliliter	64406-101	f73a7c1a-d9c9-474b-bafa-007543781603	1	2021-07-15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761178	Aduhelm	aducanumab-avwa	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
105J35OE21	ADUCANUMAB	1384260-65-4	ADUCANUMAB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64406-101-01	64406010101	1 VIAL in 1 CARTON (64406-101-01) > 1.7 mL in 1 VIAL	1 vial	2021-06-07	0000-00-00	No	No	Current

Aduhelm

NDC auxiliary status#

Observed NDC auxiliary status history#

DailyMed Billing Units#

Related Records#

Purple Book Biologic Products#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#