Is Harmony Biosciences, LLC FDA approved?

Harmony Biosciences, LLC holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Harmony Biosciences, LLC make?

2 products are listed under Harmony Biosciences, LLC in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Harmony Biosciences, LLC

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

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Registered sites: 0
Active NDC listings: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
tablet, film coated	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
harmony biosciences, llc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Wakix	PITOLISANT HYDROCHLORIDE	tablet, film coated, oral	72028-045NDA
Wakix	PITOLISANT HYDROCHLORIDE	tablet, film coated, oral	72028-178NDA

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Other companies listing pitolisant hydrochloride

Biophore India Pharmaceuticals Private Limited1 site · 38 NDC
Emnar Pharma Private Limited0 sites · 23 NDC

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Common questions

Is Harmony Biosciences, LLC FDA approved?: Harmony Biosciences, LLC holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Harmony Biosciences, LLC make?: 2 products are listed under Harmony Biosciences, LLC in the openFDA NDC Directory, most often as tablet, film 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.