Quick answers
- What is XPHOZAH 20 mg?
- XPHOZAH 20 mg is a brand name of Tenapanor, a prescription medicine. The FDA NDC Directory lists 1 XPHOZAH 20 mg product in 1 strength and form.
- Who makes XPHOZAH 20 mg?
- Ardelyx Inc holds the FDA application for XPHOZAH 20 mg (NDA213931, approved October 17, 2023).
- Is there a generic or store brand of XPHOZAH 20 mg?
- Other products of Tenapanor are listed with the FDA, but none in exactly the same strength and form as a XPHOZAH 20 mg product.
- Has XPHOZAH 20 mg been recalled?
- No recall linked to XPHOZAH 20 mg products (by their NDC code or label) appears in the FDA enforcement reports we use.
What XPHOZAH 20 mg is
Each XPHOZAH 20 mg product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Tenapanor · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| tenapanor hydrochloride 20 mg tablet, film coated (oral) | XPHOZAH 20 mg | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tenapanor →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA213931 | Ardelyx Inc | October 17, 2023 | 1 |
Companies that list XPHOZAH 20 mg
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of XPHOZAH 20 mg products.
- Ardelyx, Inc.1 product
Recalls
No recall linked to XPHOZAH 20 mg products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.