1. Home
  2. Labeler Index
  3. Napo Pharmaceuticals, Inc.
  4. 70564-802
  5. NDC Package Code: 70564-802-60 Mytesi

NDC Package 70564-802-60 Mytesi

Crofelemer Tablet, Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70564-802-60
Package Description:
60 TABLET, COATED in 1 BOTTLE
Product Code:
70564-802
Proprietary Name:
Mytesi
Non-Proprietary Name:
Crofelemer
Substance Name:
Crofelemer
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.
11-Digit NDC Billing Format:
70564080260
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1364454 - crofelemer 125 MG Delayed Release Oral Tablet
  • RxCUI: 1806878 - Mytesi 125 MG Delayed Release Oral Tablet
  • RxCUI: 1806878 - crofelemer 125 MG Delayed Release Oral Tablet [Mytesi]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Napo Pharmaceuticals, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CROFELEMER 125 mg/1
    • Pharmacologic Class(es):
  • Antidiarrheal - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA202292
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-01-2016
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 70564-802-60?

    The NDC Packaged Code 70564-802-60 is assigned to a package of 60 tablet, coated in 1 bottle of Mytesi, a human prescription drug labeled by Napo Pharmaceuticals, Inc.. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 70564-802 included in the NDC Directory?

    Yes, Mytesi with product code 70564-802 is active and included in the NDC Directory. The product was first marketed by Napo Pharmaceuticals, Inc. on August 01, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 70564-802-60?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 70564-802-60?

    The 11-digit format is 70564080260. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-270564-802-605-4-270564-0802-60