Careone Diarrhea Control Suspension
NDC Package 41520-841-26

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

Package Information

Careone Diarrhea Control (loperamide hydrochloride) suspension is •drink plenty of clear fluids to help prevent dehydration caused by diarrhea•find right dose on chart. This formulation utilizes a suspension delivery system. Marketed by American Sales Company, this product is identified by NDC 41520-841 and is authorized under FDA application ANDA091292.

Identification & Billing

NDC Package Code
41520-841-26
Package Description
120 mL in 1 BOTTLE
Product Code
41520-841
11-Digit Billing Format
41520084126
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Careone Diarrhea Control
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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 diarrhea•find right dose on chart. If possible, use weight to dose; otherwise use age.•shake well before using•only use attached measuring cup to dose productadults and children 12 years and over30 mL (6 tsp) after the first loose stool; 15 mL (3 tsp) after each subsequent loose stool; but no more than 60 mL (12 tsp) in 24 hourschildren 9-11 years (60-95 lbs)15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 45 mL (9 tsp) in 24 hourschildren 6-8 years (48-59 lbs)15 mL (3 tsp) after the first loose stool; 7.5 mL (1 ½ tsp) after each subsequent loose stool; but no more than 30 mL (6 tsp) in 24 hourschildren under 6 years (up to 47 lbs)ask a doctor

Regulatory & Marketing

Labeler Name
American Sales Company
Product Type
Human Otc Drug
FDA Application #
ANDA091292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 41520-841-26 identifies a specific commercial package of 120 ml in 1 bottle of Careone Diarrhea Control, a human over the counter drug labeled by American Sales Company. This suspension 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 American Sales Company on November 23, 2016. The current certification is valid through December 31, 2026.

How is this American Sales Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41520084126. 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)
41520-841-26
11-Digit CMS (5-4-2)
41520-0841-26

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