Is Braintree Laboratories, Inc. FDA approved?

Braintree 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 Braintree Laboratories, Inc.'s drugs manufactured?

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

What drugs does Braintree Laboratories, Inc. make?

5 products are listed under Braintree Laboratories, Inc. in the openFDA NDC Directory, most often as solution, concentrate; kit; powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Braintree Laboratories, Inc.

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

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Registered sites: 1
Active NDC listings: 5
Live patents: 1
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Braintree Laboratories, Inc.	270 Centre Street, Holbrook, Massachusetts (MA) 02343, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1000513636617357954

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human prescription drug. By marketing category: NDA 5.

Dosage form	NDCs
solution, concentrate	2
kit	1
powder, for solution	1
tablet	1

Route	NDCs
oral	4

Labeller name on the listing	NDCs
braintree laboratories, inc.	5

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10806743	PIZENSYlactitol	use	May 2037

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
GoLYTELY	Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride	powder, for solution, oral	52268-100NDA
SUFLAVE	polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution	kit	52268-550NDA
SUPREP Bowel Prep	sodium sulfate, potassium sulfate, magnesium sulfate	solution, concentrate, oral	52268-012NDA
SUPREP Bowel Prep	sodium sulfate, potassium sulfate, magnesium sulfate	solution, concentrate, oral	52268-112NDA
SUTAB	sodium sulfate, magnesium sulfate, and potassium chloride	tablet, oral	52268-201NDA

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Enquiry

Common questions

Is Braintree Laboratories, Inc. FDA approved?: Braintree 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 Braintree Laboratories, Inc.'s drugs manufactured?: The FDA register lists Holbrook, MA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Braintree Laboratories, Inc. make?: 5 products are listed under Braintree Laboratories, Inc. in the openFDA NDC Directory, most often as solution, concentrate; kit; powder, for solution. 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.