Ibsrela Tablet
NDC Package 73154-050-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ibsrela (tenapanor hydrochloride) tablets is iBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. This formulation utilizes a tablet delivery system. Marketed by Ardelyx, Inc., this product is identified by NDC 73154-050 and is authorized under FDA application NDA211801.

Identification & Billing

NDC Package Code
73154-050-06
Package Description
6 TABLET in 1 BOTTLE
Product Code
73154-050
11-Digit Billing Format
73154005006
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ibsrela
Non-Proprietary Name
Tenapanor Hydrochloride
Substance Name
Tenapanor Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TENAPANOR HYDROCHLORIDE 53.2 mg/1
Pharmacologic Class
Usage Information
IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Regulatory & Marketing

Labeler Name
Ardelyx, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211801
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-12-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (73154-050). Click a package code to view its specific billing and regulatory data.

73154-050-60
60 TABLET in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73154-050-06 identifies a specific commercial package of 6 tablet in 1 bottle of Ibsrela, a human prescription drug labeled by Ardelyx, Inc.. This tablet is formulated for oral use and contains tenapanor hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Ardelyx, Inc. on September 12, 2019. The current certification is valid through December 31, 2026.

How is this Ardelyx, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73154005006. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
73154-050-06
11-Digit CMS (5-4-2)
73154-0050-06

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.