Imodium Solution
NDC Package 50580-134-08

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

Package Information

Imodium (loperamide hydrochloride) solution is drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. This formulation utilizes a solution delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-134 and is authorized under FDA application NDA019487.

Identification & Billing

NDC Package Code
50580-134-08
Package Description
240 mL in 1 BOTTLE
Product Code
50580-134
11-Digit Billing Format
50580013408
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imodium A-d
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
Pharmacologic Class
Usage Information
Drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. If possible, use weight to dose; otherwise use age.shake well before usinguse only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.mL = milliliteradults and children 12 years and over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hourschildren 9-11 years (60-95 lbs)15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hourschildren 6-8 years (48-59 lbs)15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hourschildren 2-5 years (34 to 47 lbs)ask a doctorchildren under 2 years (up to 33 lbs)do not use

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
NDA019487
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2004
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50580-134). Click a package code to view its specific billing and regulatory data.

50580-134-04
120 mL in 1 BOTTLE
50580-134-44
120 mL in 1 BOTTLE

* 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 50580-134-08 identifies a specific commercial package of 240 ml in 1 bottle of Imodium A-d, a human over the counter drug labeled by Kenvue Brands Llc. This product is billed per "ML" milliliter and contains an estimated amount of 240 billable units per package. This solution is formulated for oral use and contains loperamide 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 Kenvue Brands Llc on July 01, 2004. The current certification is valid through December 31, 2026.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580013408. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 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)
50580-134-08
11-Digit CMS (5-4-2)
50580-0134-08

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