Is I 3 PHARMACEUTICALS, LLC FDA approved?

I 3 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 I 3 PHARMACEUTICALS, LLC's drugs manufactured?

The FDA register lists Warminster, PA. Registered operations: analytical testing, finished drug manufacture, packaging.

What drugs does I 3 PHARMACEUTICALS, LLC make?

4 products are listed under I 3 PHARMACEUTICALS, LLC in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

I 3 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: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
I 3 PHARMACEUTICALS, LLC	200 Park Avenue, Warminster, Pennsylvania (PA) 18974, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	3012763653080127275

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 3, UNAPPROVED HOMEOPATHIC 1.

Dosage form	NDCs
tablet	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
i-health, inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AZO	Urinary Pain Relief	tablet, oral	49973-301UNAPPROVED DRUG OTHER
AZO Urinary Pain Relief Maximum Strength	Phenazopyridine Hydrochloride	tablet, oral	49973-247UNAPPROVED DRUG OTHER
AZO Yeast Plus	Candida Albicans, Wood Creosote, Sodium Chloride, and Sulfur	tablet, oral	49973-667UNAPPROVED HOMEOPATHIC
Azo Urinary Tract Defense Antibacterial Protection	Methenamine, Sodium salicylate	tablet, oral	49973-011UNAPPROVED DRUG OTHER

Neighbours

Registered in the same town

Gehring-Montgomery, IncWarminster, PA
Renu Laboratories, LLCWarminster, PA

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Enquiry

Common questions

Is I 3 PHARMACEUTICALS, LLC FDA approved?: I 3 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 I 3 PHARMACEUTICALS, LLC's drugs manufactured?: The FDA register lists Warminster, PA. Registered operations: analytical testing, finished drug manufacture, packaging.
What drugs does I 3 PHARMACEUTICALS, LLC make?: 4 products are listed under I 3 PHARMACEUTICALS, LLC in the openFDA NDC Directory, most often as tablet. 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.