Is Ardelyx, Inc. FDA approved?

Ardelyx, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Ardelyx, Inc. make?

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

Ardelyx, Inc.

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

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Registered sites: 0
Active NDC listings: 4
Live patents: 24
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.

Dosage form	NDCs
tablet, film coated	3
tablet	1

Route	NDCs
oral	4

Labeller name on the listing	NDCs
ardelyx, inc.	4

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
12016856	IBSRELA, XPHOZAHtenapanor hydrochloride	substance, product	Dec 2029
8969377	IBSRELA, XPHOZAHtenapanor hydrochloride	substance, product	Dec 2029
9408840	IBSRELAtenapanor hydrochloride	use	Dec 2029
9006281	IBSRELAtenapanor hydrochloride	use	May 2030
8541448	IBSRELA, XPHOZAHtenapanor hydrochloride	substance, product	Aug 2033
10272079	XPHOZAHtenapanor hydrochloride	use	Apr 2034
10940146	XPHOZAHtenapanor hydrochloride	use	Apr 2034
12539299	IBSRELA, XPHOZAHtenapanor hydrochloride	product	Nov 2042

Product	Exclusivity	Until
XPHOZAHTENAPANOR HYDROCHLORIDE	NP New product	Oct 2026

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
IBSRELA	tenapanor hydrochloride	tablet, oral	73154-050NDA
XPHOZAH 10 mg	Tenapanor	tablet, film coated, oral	73154-110NDA
XPHOZAH 20 mg	Tenapanor	tablet, film coated, oral	73154-120NDA
XPHOZAH 30 mg	Tenapanor	tablet, film coated, oral	73154-130NDA

Compare

Other companies listing tenapanor

Valdepharm1 site · 17 NDC

Enquiry

Common questions

Is Ardelyx, Inc. FDA approved?: Ardelyx, Inc. holds no registered establishment of its own; 4 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Ardelyx, Inc. make?: 4 products are listed under Ardelyx, Inc. in the openFDA NDC Directory, most often as tablet, film coated; 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.