Is VITANE PHARMACEUTICALS, INC. FDA approved?

VITANE PHARMACEUTICALS, 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 VITANE PHARMACEUTICALS, INC.'s drugs manufactured?

The FDA register lists CONGERS, NY. Registered operations: labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does VITANE PHARMACEUTICALS, INC. make?

2 products are listed under VITANE PHARMACEUTICALS, INC. in the openFDA NDC Directory, most often as tablet; tablet, delayed release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

VITANE PHARMACEUTICALS, INC.

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

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

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
VITANE PHARMACEUTICALS, INC.	125 WELLS AVENUE, CONGERS, New York (NY) 10920, United States (USA)	Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3009790403029029638

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human otc drug. By marketing category: OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
tablet	1
tablet, delayed release	1

Route	NDCs
oral	2

Labeller name on the listing	NDCs
vitane pharmaceuticals, inc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Aspirin 81mg	Aspirin Enteric Coated Tablets 81mg	tablet, oral	60577-807OTC MONOGRAPH DRUG
Aspirin 81mg	Aspirin Enteric Coated Tablets 81mg	tablet, delayed release, oral	60577-808OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Intercos America, Inc.Congers, NY

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Enquiry

Common questions

Is VITANE PHARMACEUTICALS, INC. FDA approved?: VITANE PHARMACEUTICALS, 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 VITANE PHARMACEUTICALS, INC.'s drugs manufactured?: The FDA register lists CONGERS, NY. Registered operations: labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does VITANE PHARMACEUTICALS, INC. make?: 2 products are listed under VITANE PHARMACEUTICALS, INC. in the openFDA NDC Directory, most often as tablet; tablet, delayed 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.