Is Mallinckrodt ARD LLC FDA approved?

Mallinckrodt ARD LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Mallinckrodt ARD LLC make?

3 products are listed under Mallinckrodt ARD LLC in the openFDA NDC Directory, most often as injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mallinckrodt ARD LLC

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

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Registered sites: 0
Active NDC listings: 3
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 3.

Dosage form	NDCs
injection	3

Route	NDCs
subcutaneous	3
intramuscular	1

Labeller name on the listing	NDCs
mallinckrodt ard llc	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Acthar	Repository Corticotropin	injection, intramuscular, subcutaneous	63004-8710NDA
Acthar	repository corticotropin	injection, subcutaneous	63004-8711NDA
Acthar	repository corticotropin	injection, subcutaneous	63004-8712NDA

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Common questions

Is Mallinckrodt ARD LLC FDA approved?: Mallinckrodt ARD LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Mallinckrodt ARD LLC make?: 3 products are listed under Mallinckrodt ARD LLC in the openFDA NDC Directory, most often as injection. 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.