Loperamide Hydrochloride
NDC Package 46122-169-08

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Loperamide Hydrochloride is drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. Marketed by Amerisource Bergen, this product is identified by NDC 46122-169 and is authorized under FDA application ANDA074091.

Identification & Billing

NDC Package Code
46122-169-08
Package Description
72 TABLET in 1 BOTTLE
Product Code
46122-169
11-Digit Billing Format
46122016908
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
72 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Dosage Form
-
Usage Information
Drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. If possible, use weight to dose; otherwise, use age.adults and children 12 years and over2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hourschildren 9-11 years (60-95 lbs)1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hourschildren 6-8 years (48-59 lbs)1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hourschildren under 6 years (up to 47 lbs)ask a doctor

Regulatory & Marketing

Labeler Name
Amerisource Bergen
FDA Application #
ANDA074091
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-1993
Listing Expiration
12-31-2019
Exclude Flag
I
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 46122-169-08 identifies a specific commercial package of 72 tablet in 1 bottle of Loperamide Hydrochloride, labeled by Amerisource Bergen. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amerisource Bergen on February 01, 1993. The current certification is valid through December 31, 2019.

How is this Amerisource Bergen product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122016908. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 72 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)
46122-169-08
11-Digit CMS (5-4-2)
46122-0169-08

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