Xermelo Tablet
NDC Package 70183-125-84
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 Lexicon Pharmaceuticals, Inc., this product is identified by NDC 70183-125 and is authorized under FDA application NDA208794.
Identification & Billing
- RxCUI: 1872453 - telotristat ethyl 250 MG Oral Tablet
- RxCUI: 1872453 - telotristat ethyl 250 MG (as telotristat etiprate 328 MG) Oral Tablet
- RxCUI: 1872458 - XERMELO 250 MG Oral Tablet
- RxCUI: 1872458 - telotristat ethyl 250 MG Oral Tablet [Xermelo]
- RxCUI: 1872458 - Xermelo 250 MG (as telotristat etiprate 328 MG) Oral Tablet
Clinical Specifications
- Oral - Administration to or by way of the mouth.
- Oral - Administration to or by way of the mouth.
Regulatory & Marketing
Hierarchy Structure
- 70183 - Lexicon Pharmaceuticals, Inc.
- 70183-125 - Xermelo
- 70183-125-84 - 4 BOX in 1 CASE / 7 BLISTER PACK in 1 BOX (70183-125-21) / 3 TABLET in 1 BLISTER PACK (70183-125-03)
- 70183-125 - Xermelo
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 (70183-125). Click a package code to view its specific billing and regulatory data.
* 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 70183-125-84 identifies a specific commercial package of 4 box in 1 case / 7 blister pack in 1 box (70183-125-21) / 3 tablet in 1 blister pack (70183-125-03) of Xermelo, a human prescription drug labeled by Lexicon Pharmaceuticals, Inc.. 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 Lexicon Pharmaceuticals, Inc. on March 01, 2017. 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 Lexicon Pharmaceuticals, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 70183012584. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
