Is Lantheus Medical Imaging, Inc. FDA approved?

Lantheus Medical Imaging, 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 Lantheus Medical Imaging, Inc.'s drugs manufactured?

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

What drugs does Lantheus Medical Imaging, Inc. make?

9 products are listed under Lantheus Medical Imaging, Inc. in the openFDA NDC Directory, most often as gas; injection, powder, lyophilized, for solution; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Lantheus Medical Imaging, Inc.

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

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Registered sites: 1
Active NDC listings: 9
Live patents: 20
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Lantheus Medical Imaging, Inc.	331 Treble Cove Road, North Billerica, Massachusetts (MA) 01862, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1216602176786812

Catalogue

Drug listings by form and route

9 active NDC listings: 9 human prescription drug. By marketing category: NDA 9.

Dosage form	NDCs
gas	2
injection, powder, lyophilized, for solution	2
injection, solution	2
injection, suspension	2
kit	1

Route	NDCs
intravenous	6
respiratory (inhalation)	2

Labeller name on the listing	NDCs
lantheus medical imaging, inc.	9

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10022460	DEFINITY RTperflutren	substance, product	Dec 2035
10583207	DEFINITY, DEFINITY RTperflutren	use	Dec 2035
11395856	DEFINITY RTperflutren	substance, product	Dec 2035
10583208	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
11266750	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
11529431	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
11857646	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
11925695	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
12161730	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
9789210	DEFINITY, DEFINITY RTperflutren	use	Mar 2037
10588988	DEFINITY, DEFINITY RTperflutren	use	May 2037

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cardiolite	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	injection, powder, lyophilized, for solution, intravenous	11994-001NDA
DEFINITY RT	perflutren	injection, suspension, intravenous	11994-017NDA
Definity	perflutren	injection, suspension, intravenous	11994-011NDA
Kit for the Preparation of Technetium Tc99m Sestamibi	TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE	injection, powder, lyophilized, for solution, intravenous	11994-003NDA
NEUROLITE	Bicisate dihydrochloride	kit	11994-006NDA
TechneLite	Technetium Tc99m Generator	injection, solution, intravenous	11994-090NDA
TechneLite	Technetium Tc99m Generator	injection, solution, intravenous	11994-091NDA
Xenon	Xenon XE-133	gas, respiratory (inhalation)	11994-127NDA
Xenon	Xenon XE-133	gas, respiratory (inhalation)	11994-128NDA

Neighbours

Registered in the same town

Medical-technical Gases, Inc.North Billerica, MA
SciSafe, Inc.North Billerica, MA
Shine Spect USA, LLCNorth Billerica, MA

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Enquiry

Common questions

Is Lantheus Medical Imaging, Inc. FDA approved?: Lantheus Medical Imaging, 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 Lantheus Medical Imaging, Inc.'s drugs manufactured?: The FDA register lists North Billerica, MA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Lantheus Medical Imaging, Inc. make?: 9 products are listed under Lantheus Medical Imaging, Inc. in the openFDA NDC Directory, most often as gas; injection, powder, lyophilized, for solution; injection, 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.