Is Prinston Pharmaceutical Inc. FDA approved?

Prinston Pharmaceutical Inc. 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 Prinston Pharmaceutical Inc.'s drugs manufactured?

The FDA register lists Charlotte, NC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Prinston Pharmaceutical Inc. make?

4 products are listed under Prinston Pharmaceutical Inc. 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.

Are any Prinston Pharmaceutical Inc. products in shortage?

8 presentations are currently listed in the FDA drug shortage database under Prinston Pharmaceutical Inc., covering Clonazepam Tablet.

Prinston Pharmaceutical Inc.

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

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Registered sites: 1
Active NDC listings: 4
Live patents: 0
Shortage listings: 8
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Generics Bidco II LLC d/b/a Prinston LaboratoriesRegistrant: Prinston Pharmaceutical Inc.	3700A Woodpark Blvd., Charlotte, North Carolina (NC) 28206, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1038197968329537

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, .5 mg (NDC 43547-406-10)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, .5 mg (NDC 43547-406-11)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, .5 mg (NDC 43547-406-50)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, 1 mg (NDC 43547-407-50)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, 2 mg (NDC 43547-408-10)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, 1 mg (NDC 43547-407-11)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, 2 mg (NDC 43547-408-50)	Current	Available	10 Mar 20232 Sept 2026
Clonazepam TabletNeurology, Pediatric, Psychiatry	Clonazepam, Tablet, 1 mg (NDC 43547-407-10)	Current	Available	10 Mar 20232 Sept 2026

Catalogue

Drug listings by form and route

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

Dosage form	NDCs
tablet, film coated	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
prinston pharmaceutical inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Levetiracetam	Levetiracetam	tablet, film coated, oral	76494-528ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	76494-529ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	76494-530ANDA
Levetiracetam	Levetiracetam	tablet, film coated, oral	76494-531ANDA

Neighbours

Registered in the same town

Cardinal Health 418, Inc.Charlotte, NC
Sotera Health LLCCharlotte, NC
Pinnacle Pharma LLCCharlotte, NC

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Enquiry

Common questions

Is Prinston Pharmaceutical Inc. FDA approved?: Prinston Pharmaceutical Inc. 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 Prinston Pharmaceutical Inc.'s drugs manufactured?: The FDA register lists Charlotte, NC. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Prinston Pharmaceutical Inc. make?: 4 products are listed under Prinston Pharmaceutical Inc. 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.
Are any Prinston Pharmaceutical Inc. products in shortage?: 8 presentations are currently listed in the FDA drug shortage database under Prinston Pharmaceutical Inc., covering Clonazepam Tablet.

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.