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  5. NDC Package Code: 84441-713-10 Loperamide Hydrochloride And Simethicone

NDC Package 84441-713-10 Loperamide Hydrochloride And Simethicone

Tablet 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:
84441-713-10
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
84441-713
Proprietary Name:
Loperamide Hydrochloride And Simethicone
Non-Proprietary Name:
Loperamide Hydrochloride And Simethicone
Substance Name:
Dimethicone; Loperamide Hydrochloride
Usage Information:
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hourschildren 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hourschildren 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hourschildren 2-5 years (34 to 47 lbs) ask a doctorchildren under 2 years (up to 33 lbs) do not use
11-Digit NDC Billing Format:
84441071310
Product Type:
Human Otc Drug
Labeler Name:
Imo-gen Labs Llc
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):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA211438
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-23-2025
Listing Expiration Date:
12-31-2026
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 84441-713-10?

The NDC Packaged Code 84441-713-10 is assigned to a package of 100 tablet in 1 bottle of Loperamide Hydrochloride And Simethicone, a human over the counter drug labeled by Imo-gen Labs Llc. The product's dosage form is tablet and is administered via oral form.

Is NDC 84441-713 included in the NDC Directory?

Yes, Loperamide Hydrochloride And Simethicone with product code 84441-713 is active and included in the NDC Directory. The product was first marketed by Imo-gen Labs Llc on October 23, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 84441-713-10?

The 11-digit format is 84441071310. 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
5-3-284441-713-105-4-284441-0713-10