Is Neos Therapeutics Brands, LLC FDA approved?

Neos Therapeutics Brands, LLC holds no registered establishment of its own; 9 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Neos Therapeutics Brands, LLC make?

9 products are listed under Neos Therapeutics Brands, LLC 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.

Neos Therapeutics Brands, LLC

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

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Registered sites: 0
Active NDC listings: 9
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

9 active NDC listings: 9 human prescription drug. By marketing category: NDA 9.

Dosage form	NDCs
tablet, orally disintegrating	9

Route	NDCs
oral	9

Labeller name on the listing	NDCs
neos therapeutics brands, llc	9

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Adzenys XR-ODT	Amphetamine	tablet, orally disintegrating, oral	70165-005NDA
Adzenys XR-ODT	Amphetamine	tablet, orally disintegrating, oral	70165-010NDA
Adzenys XR-ODT	Amphetamine	tablet, orally disintegrating, oral	70165-015NDA
Adzenys XR-ODT	Amphetamine	tablet, orally disintegrating, oral	70165-020NDA
Adzenys XR-ODT	Amphetamine	tablet, orally disintegrating, oral	70165-025NDA
Adzenys XR-ODT	Amphetamine	tablet, orally disintegrating, oral	70165-030NDA
Cotempla XR-ODT	Methylphenidate	tablet, orally disintegrating, oral	70165-100NDA
Cotempla XR-ODT	Methylphenidate	tablet, orally disintegrating, oral	70165-200NDA
Cotempla XR-ODT	Methylphenidate	tablet, orally disintegrating, oral	70165-300NDA

Compare

Other companies listing amphetamine

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Amneal Pharmaceuticals NY LLC0 sites · 337 NDC

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Common questions

Is Neos Therapeutics Brands, LLC FDA approved?: Neos Therapeutics Brands, LLC holds no registered establishment of its own; 9 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Neos Therapeutics Brands, LLC make?: 9 products are listed under Neos Therapeutics Brands, LLC 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.