Is Aprecia Pharmaceuticals, LLC FDA approved?

Aprecia Pharmaceuticals, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Aprecia Pharmaceuticals, LLC's drugs manufactured?

The FDA register lists Mason, OH. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does Aprecia Pharmaceuticals, LLC make?

4 products are listed under Aprecia Pharmaceuticals, LLC in the openFDA NDC Directory, most often as tablet, for suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aprecia Pharmaceuticals, LLC

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

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Registered sites: 1
Active NDC listings: 4
Live patents: 12
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aprecia Pharmaceuticals, LLC	7200 Industrial Row Drive, Suite 200, Mason, Ohio (OH) 45040, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3012061714148914927

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
tablet, for suspension	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
aprecia pharmaceuticals, llc	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11160786	SPRITAMlevetiracetam	product	Mar 2034
9339489	SPRITAMlevetiracetam	product	Mar 2034
9669009	SPRITAMlevetiracetam	use	Mar 2034

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Spritam	levetiracetam	tablet, for suspension, oral	43485-101NDA
Spritam	levetiracetam	tablet, for suspension, oral	43485-102NDA
Spritam	levetiracetam	tablet, for suspension, oral	43485-103NDA
Spritam	levetiracetam	tablet, for suspension, oral	43485-104NDA

Neighbours

Registered in the same town

Institutional Care PharmacyMason, OH

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Enquiry

Common questions

Is Aprecia Pharmaceuticals, LLC FDA approved?: Aprecia Pharmaceuticals, LLC holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Aprecia Pharmaceuticals, LLC's drugs manufactured?: The FDA register lists Mason, OH. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does Aprecia Pharmaceuticals, LLC make?: 4 products are listed under Aprecia Pharmaceuticals, LLC in the openFDA NDC Directory, most often as tablet, for suspension. 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.