Is CooperSurgical, Inc. FDA approved?

CooperSurgical, Inc. holds 2 FDA-registered establishments 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 CooperSurgical, Inc.'s drugs manufactured?

The FDA register lists North Tonawanda, NY; Trumbull, CT. Registered operations: analytical testing, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does CooperSurgical, Inc. make?

3 products are listed under CooperSurgical, Inc. in the openFDA NDC Directory, most often as intrauterine device; jelly. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CooperSurgical, Inc.

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

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Registered sites: 2
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture2Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CooperSurgical, Inc.	825 Wurlitzer Drive, North Tonawanda, New York (NY) 14120, United States (USA)	Finished drug manufacture	1316626824716877
Coopersurgical, Inc.Registrant: CooperSurgical, Inc.	95 Corporate Drive, Trumbull, Connecticut (CT) 06611, United States (USA)	Analytical testing, Finished drug manufacture, Packaging, Relabelling, Repackaging	1216677118670081

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 2, UNAPPROVED DRUG OTHER 1.

Dosage form	NDCs
intrauterine device	2
jelly	1

Route	NDCs
intrauterine	2
vaginal	1

Labeller name on the listing	NDCs
coopersurgical, inc.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ParaGard T 380A	Copper	intrauterine device, intrauterine	59365-5128NDA
ParaGard T 380A	Copper	intrauterine device, intrauterine	59365-5129NDA
TRIMO SAN	Oxyquinoline Sulfate and Sodium Lauryl Sulfate	jelly, vaginal	59365-5030UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is CooperSurgical, Inc. FDA approved?: CooperSurgical, Inc. holds 2 FDA-registered establishments 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 CooperSurgical, Inc.'s drugs manufactured?: The FDA register lists North Tonawanda, NY; Trumbull, CT. Registered operations: analytical testing, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does CooperSurgical, Inc. make?: 3 products are listed under CooperSurgical, Inc. in the openFDA NDC Directory, most often as intrauterine device; jelly. 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.