IBSRELA
- Product NDC
- 73154-050
- 11-digit product format
- 731540050
- Labeler code
- 73154
- Product ID
- 73154-050_f077d878-d495-417c-b464-3e7c0c831be7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tenapanor hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ardelyx, Inc.
- Application
- NDA211801
- Marketing category
- NDA
- Marketing start
- 2019-09-12
- Substance
- TENAPANOR HYDROCHLORIDE
- Active strength
- 53.2 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
- IBSRELA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TENAPANOR HYDROCHLORIDE | 53.2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50605O2ZNS |
| Rxcui | 2199679, 2199685 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73154-050-06 | IBSRELA | 6 in 1 BOTTLE | TABLET | 6 | | 11 |
| 73154-050-60 | IBSRELA | 60 in 1 BOTTLE | TABLET | 60 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73154-050 | IBSRELA (TENAPANOR HYDROCHLORIDE) TABLET [ARDELYX, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250323_2102da5f-a1a0-4ac7-a1f6-38698cf7273a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73154-050-06 | 73154005006 | 6 TABLET in 1 BOTTLE (73154-050-06) | 6 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |
| 73154-050-60 | 73154005060 | 60 TABLET in 1 BOTTLE (73154-050-60) | 60 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |