Private Label Distributor Tablet
NDC Package 47682-021-50

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

Private Label Distributor (loperamide hcl 2 mg) 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 stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours. This formulation utilizes a tablet delivery system. Marketed by Unifirst First Aid Corporation, this product is identified by NDC 47682-021 and is authorized under FDA application ANDA074091.

Identification & Billing

NDC Package Code
47682-021-50
Package Description
50 PACKET in 1 BOX, UNIT-DOSE / 1 TABLET in 1 PACKET
Product Code
47682-021
11-Digit Billing Format
47682002150
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Private Label Distributor
Non-Proprietary Name
Loperamide Hcl 2 Mg
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 stool followed by 1 caplet after each subsequent loose stool 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
Unifirst First Aid Corporation
Product Type
Human Otc Drug
FDA Application #
ANDA074091
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2008
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 (47682-021). Click a package code to view its specific billing and regulatory data.

47682-021-25
25 PACKET in 1 BOX, UNIT-DOSE / 1 TABLET in 1 PACKET
47682-021-30
30 PACKET in 1 BOX, UNIT-DOSE / 1 TABLET in 1 PACKET
47682-021-75
75 PACKET in 1 BOX, UNIT-DOSE / 1 TABLET in 1 PACKET

* 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 47682-021-50 identifies a specific commercial package of 50 packet in 1 box, unit-dose / 1 tablet in 1 packet of Private Label Distributor, a human over the counter drug labeled by Unifirst First Aid Corporation. 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 Unifirst First Aid Corporation on December 30, 2008. The current certification is valid through December 31, 2026.

How is this Unifirst First Aid Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47682002150. 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)
47682-021-50
11-Digit CMS (5-4-2)
47682-0021-50

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