Motofen Tablet
NDC Package 83107-011-10

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

Package Information

Motofen (difenoxin and atropine sulfate) tablets is a medication used to treat diarrhea. This formulation utilizes a tablet delivery system. Marketed by Legacy Pharma Usa Inc., this product is identified by NDC 83107-011 and is authorized under FDA application NDA017744.

Identification & Billing

NDC Package Code
83107-011-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
83107-011
11-Digit Billing Format
83107001110
RxNorm Crosswalk
  • RxCUI: 1190738 - difenoxin 1 MG / atropine sulfate 0.025 MG Oral Tablet
  • RxCUI: 1190738 - atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet
  • RxCUI: 1190740 - Motofen 1 MG / 0.025 MG Oral Tablet
  • RxCUI: 1190740 - atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG Oral Tablet [Motofen]
  • RxCUI: 1190740 - Motofen (atropine sulfate 0.025 MG / difenoxin hydrochloride 1 MG) Oral Tablet

Clinical Specifications

Proprietary Name
Motofen
Non-Proprietary Name
Difenoxin And Atropine Sulfate
Substance Name
Atropine Sulfate; Difenoxin 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)
Pharmacologic Class
Usage Information
This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Difenoxin is similar to opioid pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Legacy Pharma Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017744
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2026
Listing Expiration
12-31-2027
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 83107-011-10 identifies a specific commercial package of 100 tablet in 1 bottle of Motofen, a human prescription drug labeled by Legacy Pharma Usa Inc.. This tablet is formulated for oral use and contains atropine sulfate; difenoxin 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 Legacy Pharma Usa Inc. on January 01, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat diarrhea. It helps to decrease the number and frequency of bowel movements. It works by slowing the movement of the intestines. Difenoxin is similar to opioid pain relievers, but it acts mainly to slow the gut. Atropine belongs to a class of drugs known as anticholinergics, which help to dry up body fluids and also slow gut movement.

How is this Legacy Pharma Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83107001110. 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)
83107-011-10
11-Digit CMS (5-4-2)
83107-0011-10

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