Is Janssen Cilag SpA FDA approved?

Janssen Cilag SpA holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Janssen Cilag SpA make?

11 products are listed under Janssen Cilag SpA in the openFDA NDC Directory, most often as tablet, film coated; tablet; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Janssen Cilag SpA

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 11
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

11 active NDC listings: 11 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 11.

Dosage form	NDCs
tablet, film coated	8
tablet	2
capsule, gelatin coated	1

Route	NDCs

Labeller name on the listing	NDCs
janssen cilag spa	11

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Acetaminophen 325 mg Guaifenesin 200 mg	tablet, film coated	62579-411DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride	tablet, film coated	62579-402DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride	tablet, film coated	62579-679DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Guaifenesin, and Phenylephrine hydrochloride	tablet, film coated	62579-401DRUG FOR FURTHER PROCESSING
-	Acetaminophen, Guaifenesin, and Phenylephrine hydrochloride	tablet, film coated	62579-680DRUG FOR FURTHER PROCESSING
-	Cetirizine Hydrochloride	tablet, film coated	62579-726DRUG FOR FURTHER PROCESSING
-	Diphenhydramine Hydrochloride and Phenylephrine Hydrochloride	tablet, film coated	62579-560DRUG FOR FURTHER PROCESSING
-	Phenylephrine Hydrochloride	tablet	62579-546DRUG FOR FURTHER PROCESSING
-	Phenylephrine Hydrochloride	tablet	62579-550DRUG FOR FURTHER PROCESSING
-	dimethyl fumarate	capsule, gelatin coated	62579-301DRUG FOR FURTHER PROCESSING
-	diphenhydramine hydrochloride	tablet, film coated	62579-226DRUG FOR FURTHER PROCESSING

Compare

Other companies listing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

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Morning Star OTC1 site · 9 NDC
Genomma Lab USA, Inc.0 sites · 44 NDC
RB Health (US) LLC0 sites · 15 NDC

Enquiry

Common questions

Is Janssen Cilag SpA FDA approved?: Janssen Cilag SpA holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Janssen Cilag SpA make?: 11 products are listed under Janssen Cilag SpA in the openFDA NDC Directory, most often as tablet, film coated; tablet; capsule, gelatin coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.