Is Aytu Therapeutics, LLC FDA approved?

Aytu Therapeutics, LLC 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 Aytu Therapeutics, LLC make?

11 products are listed under Aytu Therapeutics, LLC in the openFDA NDC Directory, most often as capsule, extended release; tablet, extended release; suspension, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aytu Therapeutics, LLC

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

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Registered sites: 0
Active NDC listings: 11
Labeller names: 2
Live patents: 3
Countries: 0

Catalogue

Drug listings by form and route

11 active NDC listings: 11 human prescription drug. By marketing category: NDA 11.

Dosage form	NDCs
capsule, extended release	6
tablet, extended release	4
suspension, extended release	1

Route	NDCs
oral	11

Labeller name on the listing	NDCs
aytu biopharma, inc.	6
aytu therapeutics, llc	5

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9522191	KARBINAL ERcarbinoxamine maleate	product	Jun 2027
8062667	KARBINAL ERcarbinoxamine maleate	product	Mar 2029
8236285	ZOLPIMISTzolpidem tartrate	substance, product	Aug 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
EXXUA	gepirone	tablet, extended release, oral	23594-150NDA
EXXUA	gepirone	tablet, extended release, oral	23594-151NDA
EXXUA	gepirone	tablet, extended release, oral	23594-152NDA
EXXUA	gepirone	tablet, extended release, oral	23594-153NDA
Karbinal ER	Carbinoxamine Maleate	suspension, extended release, oral	23594-101NDA
METADATE CD	methylphenidate hydrochloride	capsule, extended release, oral	69654-579NDA
METADATE CD	methylphenidate hydrochloride	capsule, extended release, oral	69654-580NDA
METADATE CD	methylphenidate hydrochloride	capsule, extended release, oral	69654-581NDA
METADATE CD	methylphenidate hydrochloride	capsule, extended release, oral	69654-582NDA
METADATE CD	methylphenidate hydrochloride	capsule, extended release, oral	69654-583NDA
METADATE CD	methylphenidate hydrochloride	capsule, extended release, oral	69654-584NDA

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Enquiry

Common questions

Is Aytu Therapeutics, LLC FDA approved?: Aytu Therapeutics, LLC 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 Aytu Therapeutics, LLC make?: 11 products are listed under Aytu Therapeutics, LLC in the openFDA NDC Directory, most often as capsule, extended release; tablet, extended release; suspension, extended release. 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.