Is Nuvalent, Inc. FDA approved?

Nuvalent, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Nuvalent, Inc. make?

2 products are listed under Nuvalent, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Nuvalent, Inc.

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

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Registered sites: 0
Active NDC listings: 2
Live patents: 8
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
tablet, film coated	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
nuvalent, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11542278	JIDEYTROzidesamtinib	substance, product	May 2041
12054498	JIDEYTROzidesamtinib	use	May 2041
12043626	JIDEYTROzidesamtinib	substance, product	Sept 2042
12630560	JIDEYTROzidesamtinib	use	Sept 2042

Product	Exclusivity	Until
JIDEYTROZIDESAMTINIB	NCE New chemical entity	Jul 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
JIDEYTRO	zidesamtinib	tablet, film coated, oral	85001-101NDA
JIDEYTRO	zidesamtinib	tablet, film coated, oral	85001-102NDA

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Other companies listing zidesamtinib

Patheon Manufacturing Services LLC19 sites · 319 NDC

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Common questions

Is Nuvalent, Inc. FDA approved?: Nuvalent, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Nuvalent, Inc. make?: 2 products are listed under Nuvalent, Inc. in the openFDA NDC Directory, most often as tablet, film coated. 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.