Labeler · US market

Biogen MA Inc.

Biogen MA Inc. is a US drug labeler with US FDA registrations covering 2 drug concepts (1 currently active) across 7 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes64406

Active drugs1

Registrations3 active / 6

Packages7

Sole supplier of1 drugs

Portfolio2 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Zuranolone capsule	rx	3	4	SUPPLYING
Tocilizumab injection	rx	3	3	DISCONTINUED

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

Zuranolonerx

At a glance

TypeLabeler
Labeler codes64406
Filing names1
Drugs (active)1
Drugs (all time)2
US registrations6
Packages7

Recent events

Shortages, recalls, and registration changes across all filing names.

Dec 9, 2020
RECALLRecall (Class II): Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx…
Jun 23, 2020
RECALLRecall (Class III): Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc.,…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.