Mytesi Tablet, Coated
NDC Package 70564-802-60

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

Package Information

Mytesi (crofelemer) tablets is crofelemer is used to relieve symptoms of diarrhea in HIV/AIDS patients who are taking medicines to treat HIV infection. This formulation utilizes a tablet, coated delivery system. Marketed by Napo Pharmaceuticals, Inc., this product is identified by NDC 70564-802 and is authorized under FDA application NDA202292.

Identification & Billing

NDC Package Code
70564-802-60
Package Description
60 TABLET, COATED in 1 BOTTLE
Product Code
70564-802
11-Digit Billing Format
70564080260
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mytesi
Non-Proprietary Name
Crofelemer
Substance Name
Crofelemer
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CROFELEMER 125 mg/1
Pharmacologic Class
Antidiarrheal - [EPC] (Established Pharmacologic Class)
Usage Information
Crofelemer is used to relieve symptoms of diarrhea in HIV/AIDS patients who are taking medicines to treat HIV infection. This medication may reduce the number of watery stools you have and help you better tolerate your HIV medications. It works by preventing water and minerals from entering into the intestines, causing the stools to be more solid. Crofelemer should not be used to treat diarrhea caused by infections.

Regulatory & Marketing

Labeler Name
Napo Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202292
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-01-2016
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 70564-802-60 identifies a specific commercial package of 60 tablet, coated in 1 bottle of Mytesi, a human prescription drug labeled by Napo Pharmaceuticals, Inc.. This tablet, coated is formulated for oral use and contains crofelemer 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 Napo Pharmaceuticals, Inc. on August 01, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Crofelemer is used to relieve symptoms of diarrhea in HIV/AIDS patients who are taking medicines to treat HIV infection. This medication may reduce the number of watery stools you have and help you better tolerate your HIV medications. It works by preventing water and minerals from entering into the intestines, causing the stools to be more solid. Crofelemer should not be used to treat diarrhea caused by infections.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70564080260. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
70564-802-60
11-Digit CMS (5-4-2)
70564-0802-60

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