Labeler · US market

Janssen Cilag SpA

Janssen Cilag SpA is a US drug labeler with US FDA registrations covering 8 drug concepts (8 currently active) across 11 packages. It is currently the only active US supplier of 5 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes62579

Active drugs8

Registrations11 active / 11

Packages11

Sole supplier of5 drugs

Portfolio8 drugs · US

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

Drug	Type	NDCs	Packages	Status
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride tablet, film coated	other	2	2	SUPPLYING
Phenylephrine Hydrochloride tablet	otc	2	2	SUPPLYING
Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride tablet, film coated	other	2	2	SUPPLYING
Dimethyl Fumarate capsule, gelatin coated	other	1	1	SUPPLYING
Diphenhydramine Hydrochloride tablet, film coated	otc	1	1	SUPPLYING
Acetaminophen 325 Mg Guaifenesin 200 Mg tablet, film coated	other	1	1	SUPPLYING
Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride tablet, film coated	other	1	1	SUPPLYING
Cetirizine Hydrochloride tablet, film coated	other	1	1	SUPPLYING

Sole US supplier

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

At a glance

TypeLabeler
Labeler codes62579
Filing names1
Drugs (active)8
Drugs (all time)8
US registrations11
Packages11

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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.