Xermelo Tablet
NDC Package 70720-125-85

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

Package Information

Xermelo (telotristat ethyl) tablets is a medication used along with another drug (a somatostatin analog such as octreotide) to treat diarrhea due to carcinoid syndrome. This formulation utilizes a tablet delivery system. Marketed by Tersera Therapeutics Llc, this product is identified by NDC 70720-125 and is authorized under FDA application NDA208794.

Identification & Billing

NDC Package Code
70720-125-85
Package Description
4 BOX in 1 CASE / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK
Product Code
70720-125
11-Digit Billing Format
70720012585
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xermelo
Non-Proprietary Name
Telotristat Ethyl
Substance Name
Telotristat Ethyl
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)
TELOTRISTAT ETHYL 250 mg/1
Pharmacologic Class
Usage Information
This medication is used along with another drug (a somatostatin analog such as octreotide) to treat diarrhea due to carcinoid syndrome. Telotristat helps to reduce the number of bowel movements that you may have.

Regulatory & Marketing

Labeler Name
Tersera Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA208794
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-05-2020
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70720-125-85 identifies a specific commercial package of 4 box in 1 case / 1 blister pack in 1 box (70720-125-22) / 21 tablet in 1 blister pack of Xermelo, a human prescription drug labeled by Tersera Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This tablet is formulated for oral use and contains telotristat ethyl 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 Tersera Therapeutics Llc on October 05, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with another drug (a somatostatin analog such as octreotide) to treat diarrhea due to carcinoid syndrome. Telotristat helps to reduce the number of bowel movements that you may have.

How is this Tersera Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70720012585. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 total billable units per package. 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)
70720-125-85
11-Digit CMS (5-4-2)
70720-0125-85

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