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  5. NDC Package Code: 54766-200-04 Motofen

NDC Package 54766-200-04 Motofen

Difenoxin And Atropine Sulfate Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
54766-200-04
Package Description:
4 TABLET in 1 BLISTER PACK
Product Code:
54766-200
Proprietary Name:
Motofen
Non-Proprietary Name:
Difenoxin And Atropine Sulfate
Substance Name:
Atropine Sulfate; Difenoxin Hydrochloride
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.
11-Digit NDC Billing Format:
54766020004
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sebela Pharmaceuticals Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ATROPINE SULFATE .025 mg/1
  • DIFENOXIN HYDROCHLORIDE 1 mg/1
    • Pharmacologic Class(es):
  • Anticholinergic - [EPC] (Established Pharmacologic Class)
  • Antidiarrheal - [EPC] (Established Pharmacologic Class)
  • Cholinergic Antagonists - [MoA] (Mechanism of Action)
  • Cholinergic Muscarinic Antagonist - [EPC] (Established Pharmacologic Class)
  • Cholinergic Muscarinic Antagonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    Yes
    FDA Application Number:
    NDA017744
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-11-2017
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    54766-200-10100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54766-200-04?

    The NDC Packaged Code 54766-200-04 is assigned to a package of 4 tablet in 1 blister pack of Motofen, a human prescription drug labeled by Sebela Pharmaceuticals Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 54766-200 included in the NDC Directory?

    Yes, Motofen with product code 54766-200 is active and included in the NDC Directory. The product was first marketed by Sebela Pharmaceuticals Inc. on April 11, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 54766-200-04?

    The 11-digit format is 54766020004. 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
    5-3-254766-200-045-4-254766-0200-04