XPHOZAH 10 mg
- Product NDC
- 73154-110
- 11-digit product format
- 731540110
- Labeler code
- 73154
- Product ID
- 73154-110_4555be24-05c0-4145-80c4-2fbd64d08e52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tenapanor
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Ardelyx, Inc.
- Application
- NDA213931
- Marketing category
- NDA
- Marketing start
- 2023-10-17
- Substance
- TENAPANOR HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA], Sodium-Hydrogen Exchanger 3 Inhibitor [EPC], Sodium-Hydrogen Exchanger 3 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- XPHOZAH 10 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TENAPANOR HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50605O2ZNS |
| Rxcui | 2669440, 2669446, 2669448, 2669450, 2669452, 2669454 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73154-110-14 | XPHOZAH 10 mg | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 17 |
| 73154-110-60 | XPHOZAH 10 mg | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 17 |
| 73154-110-99 | XPHOZAH 10 mg | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73154-110 | XPHOZAH 10 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 20 MG (TENAPANOR) TABLET, FILM COATED XPHOZAH 30 MG (TENAPANOR) TABLET, FILM COATED [ARDELYX, INC.] | 16 | Current NDC, 3 package rows | 20250502_c57e279c-0f1b-4238-81b7-4e0dc0cc60c5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 73154-110-14 | 73154011014 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-14) | 2023-10-17 | No | No | Current |
| 73154-110-60 | 73154011060 | 60 TABLET, FILM COATED in 1 BOTTLE (73154-110-60) | 2023-10-17 | No | No | Current |
| 73154-110-99 | 73154011099 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-99) | 2023-10-17 | Yes | No | Current |