Imodium A-d Capsule, Liquid Filled
NDC Package 50580-367-01

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 A-d (loperamide hydrochloride) capsules is drink plenty of clear fluids to help prevent dehydration caused by diarrheanot for use in children under 12 years of ageadults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-367 and is authorized under FDA application NDA021855.

Identification & Billing

NDC Package Code
50580-367-01
Package Description
1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
50580-367
11-Digit Billing Format
50580036701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imodium A-d
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Drink plenty of clear fluids to help prevent dehydration caused by diarrheanot for use in children under 12 years of ageadults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
NDA021855
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-11-2016
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 (50580-367). Click a package code to view its specific billing and regulatory data.

50580-367-02
2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

* 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 50580-367-01 identifies a specific commercial package of 1 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Imodium A-d, a human over the counter drug labeled by Kenvue Brands Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule, liquid filled 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 11, 2016. 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: 50580036701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
50580-367-01
11-Digit CMS (5-4-2)
50580-0367-01

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