Is Xeris Pharmaceuticals, Inc. FDA approved?

Xeris Pharmaceuticals, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Xeris Pharmaceuticals, Inc. make?

6 products are listed under Xeris Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as injection, solution; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Xeris Pharmaceuticals, Inc.

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

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Registered sites: 0
Active NDC listings: 6
Live patents: 9
Countries: 0

Catalogue

Drug listings by form and route

6 active NDC listings: 6 human prescription drug. By marketing category: NDA 6.

Dosage form	NDCs
injection, solution	4
tablet	2

Route	NDCs
subcutaneous	4
oral	2

Labeller name on the listing	NDCs
xeris pharmaceuticals, inc.	6

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11590205	GVOKE HYPOPEN, GVOKE KIT, GVOKE PFSglucagon	product	Apr 2036
9649364	GVOKE HYPOPEN, GVOKE PFSglucagon	product	Apr 2036

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Gvoke HypoPen 0.5 mg Auto-Injector	glucagon injection, solution	injection, solution, subcutaneous	72065-120NDA
Gvoke HypoPen 1 mg Auto-Injector	glucagon injection, solution	injection, solution, subcutaneous	72065-121NDA
Gvoke Kit	glucagon injection, solution	injection, solution, subcutaneous	72065-140NDA
Gvoke PFS 1 mg Pre-filled Syringe	glucagon injection, solution	injection, solution, subcutaneous	72065-131NDA
Keveyis	Dichlorphenamide	tablet, oral	72065-001NDA
Recorlev	Levoketoconazole	tablet, oral	72065-003NDA

Enquiry

Common questions

Is Xeris Pharmaceuticals, Inc. FDA approved?: Xeris Pharmaceuticals, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Xeris Pharmaceuticals, Inc. make?: 6 products are listed under Xeris Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as injection, solution; 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.