Leader Anti Diarrheal Tablet, Film Coated
NDC Package 70000-0589-1

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

Package Information

Leader Anti Diarrheal (loperamide hcl) tablets is see also Warning section. This formulation utilizes a tablet, film coated delivery system. Marketed by Cardinal Health 110, Llc. Dba Leader, this product is identified by NDC 70000-0589 and is authorized under FDA application ANDA075232.

Identification & Billing

NDC Package Code
70000-0589-1
Package Description
24 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
70000-0589
11-Digit Billing Format
70000058901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
24 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Leader Anti Diarrheal
Non-Proprietary Name
Loperamide Hcl
Substance Name
Loperamide Hydrochloride
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
See also Warning section. This medication is used to treat sudden diarrhea (including traveler's diarrhea). It works by slowing down the movement of the gut. This decreases the number of bowel movements and makes the stool less watery. Loperamide is also used to reduce the amount of discharge in patients who have had an ileostomy. It is also used to treat ongoing diarrhea in people with inflammatory bowel disease. Loperamide treats only the symptoms, not the cause of the diarrhea (e.g., infection). Treatment of other symptoms and the cause of the diarrhea should be determined by your doctor.

Regulatory & Marketing

Labeler Name
Cardinal Health 110, Llc. Dba Leader
Product Type
Human Otc Drug
FDA Application #
ANDA075232
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2021
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 70000-0589-1 identifies a specific commercial package of 24 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Leader Anti Diarrheal, a human over the counter drug labeled by Cardinal Health 110, Llc. Dba Leader. This tablet, film coated 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 Cardinal Health 110, Llc. Dba Leader on October 07, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

See also Warning section. This medication is used to treat sudden diarrhea (including traveler's diarrhea). It works by slowing down the movement of the gut. This decreases the number of bowel movements and makes the stool less watery. Loperamide is also used to reduce the amount of discharge in patients who have had an ileostomy. It is also used to treat ongoing diarrhea in people with inflammatory bowel disease. Loperamide treats only the symptoms, not the cause of the diarrhea (e.g., infection). Treatment of other symptoms and the cause of the diarrhea should be determined by your doctor.

How is this Cardinal Health 110, Llc. Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000058901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 24 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 (5-4-1)
70000-0589-1
11-Digit CMS (5-4-2)
70000-0589-01

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