Is Orexo US, Inc. FDA approved?

Orexo US, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Orexo US, Inc. make?

6 products are listed under Orexo US, Inc. in the openFDA NDC Directory, most often as tablet, orally disintegrating. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Orexo US, Inc.

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

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Registered sites: 0
Active NDC listings: 6
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

6 active NDC listings: 6 human prescription drug. By marketing category: NDA 6.

Dosage form	NDCs
tablet, orally disintegrating	6

Route	NDCs
sublingual	6

Labeller name on the listing	NDCs
orexo us, inc.	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	tablet, orally disintegrating, sublingual	54123-114NDA
Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	tablet, orally disintegrating, sublingual	54123-907NDA
Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	tablet, orally disintegrating, sublingual	54123-914NDA
Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	tablet, orally disintegrating, sublingual	54123-929NDA
Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	tablet, orally disintegrating, sublingual	54123-957NDA
Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride	tablet, orally disintegrating, sublingual	54123-986NDA

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Other companies listing buprenorphine hydrochloride and naloxone hydrochloride

PAI Holdings, LLC1 site · 146 NDC
Edenbridge Pharmaceuticals LLC.0 sites · 44 NDC

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Common questions

Is Orexo US, Inc. FDA approved?: Orexo US, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Orexo US, Inc. make?: 6 products are listed under Orexo US, Inc. in the openFDA NDC Directory, most often as tablet, orally disintegrating. 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.