Handy Solutions Anti-diarrheal Tablet
NDC Package 67751-162-01

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

Package Information

Handy Solutions Anti-diarrheal (loperamide hydrochloride) tablets is do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea  Adults and children (12 years and older): Take 2 caplets after the first loose bowel movement followed by 1 caplet after each subsequent loose bowel movement but no more than 4 caplets in 24 hours. This formulation utilizes a tablet delivery system. Marketed by Navajo Manufacturing Company Inc., this product is identified by NDC 67751-162 and is authorized under FDA application ANDA074091.

Identification & Billing

NDC Package Code
67751-162-01
Package Description
1 POUCH in 1 CARTON / 1 TABLET in 1 POUCH
Product Code
67751-162
11-Digit Billing Format
67751016201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Handy Solutions Anti-diarrheal
Non-Proprietary Name
Loperamide Hydrochloride
Substance Name
Loperamide Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 2 mg/1
Pharmacologic Class
Usage Information
Do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea  Adults and children (12 years and older): Take 2 caplets after the first loose bowel movement followed by 1 caplet after each subsequent loose bowel movement but no more than 4 caplets in 24 hours.  Children under 12 years: Do not give to children under 12 years of age.

Regulatory & Marketing

Labeler Name
Navajo Manufacturing Company Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA074091
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-2016
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 67751-162-01 identifies a specific commercial package of 1 pouch in 1 carton / 1 tablet in 1 pouch of Handy Solutions Anti-diarrheal, a human over the counter drug labeled by Navajo Manufacturing Company Inc.. This tablet 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 Navajo Manufacturing Company Inc. on September 21, 2016. The current certification is valid through December 31, 2026.

How is this Navajo Manufacturing Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67751016201. 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)
67751-162-01
11-Digit CMS (5-4-2)
67751-0162-01

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