Active ingredient
Tenapanor
4 finished FDA listings contain Tenapanor as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TENAPANOR, TENAPANOR HYDROCHLORIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/1 · 20 mg/1 · 30 mg/1 · 53.2 mg/1
- Brand names in FDA listings
- Ibsrela, Xphozah 10 Mg, Xphozah 20 Mg, Xphozah 30 Mg
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2199674
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 211801 | ARDELYX INC | 2019-09-12 | 1 |
| NDA 213931 | ARDELYX INC | 2023-10-17 | 3 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.