Is Northeast Laboratories, Inc. FDA approved?

Northeast Laboratories, 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 Northeast Laboratories, Inc.'s registered sites?

The FDA register lists Rocky Hill, CT. Registered operations: analytical testing.

What drugs does Northeast Laboratories, Inc. make?

5 products are listed under Northeast Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; capsule; capsule, liquid filled. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Northeast Laboratories, Inc.

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

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Registered sites: 1
Active NDC listings: 5
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Northeast Laboratories, Inc.	30 Cold Spring Rd, Rocky Hill, Connecticut (CT) 06067, United States (USA)	Analytical testing	3001743770086650488

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human otc drug. By marketing category: ANDA 2, NDA 2, OTC MONOGRAPH DRUG 1.

Dosage form	NDCs
tablet	2
capsule	1
capsule, liquid filled	1
tablet, delayed release	1

Route	NDCs
oral	5

Labeller name on the listing	NDCs
northeast pharma	3
northeast pharma	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ANTI-DIARRHEAL	LOPERAMIDE HYDROCHLORIDE	capsule, liquid filled, oral	80136-851NDA
Acid Reducer	Omeprazole	tablet, delayed release, oral	80136-852ANDA
Cetirizine HCl	Cetirizine HCl	capsule, oral	80136-856NDA
Loperamide Hydrochloride and Simethicone	Loperamide Hydrochloride and Simethicone	tablet, oral	80136-384ANDA
Nighttime Sleep-aid	Diphenhydramine HCl	tablet, oral	80136-785OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Simoniz Saniclean LLCRocky Hill, CT

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Enquiry

Common questions

Is Northeast Laboratories, Inc. FDA approved?: Northeast Laboratories, 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 Northeast Laboratories, Inc.'s registered sites?: The FDA register lists Rocky Hill, CT. Registered operations: analytical testing.
What drugs does Northeast Laboratories, Inc. make?: 5 products are listed under Northeast Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; capsule; capsule, liquid filled. 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.