Loperamide Hydrochloride
NDC Package 17856-0618-5

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

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

Loperamide Hydrochloride is use enclosed dosage cup to accurately measure dosage as noted belowdrink plenty of clear fluids to help prevent dehydration, which may accompany diarrheafind right dose on chart. Marketed by Atlantic Biologicals Corps, this product is identified by NDC 17856-0618 and is authorized under FDA application ANDA074352.

Identification & Billing

NDC Package Code
17856-0618-5
Package Description
5 mL in 1 CUP
Product Code
17856-0618
11-Digit Billing Format
17856061805
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Dosage Form
-
Usage Information
Use enclosed dosage cup to accurately measure dosage as noted belowdrink plenty of clear fluids to help prevent dehydration, which may accompany diarrheafind right dose on chart. If possible, use weight to dose; otherwise, use age.adults and children 12 years and older4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a daychildren 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a daychildren 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a daychildren under 6 years (up to 47 lbs)ask a doctor (not intended for use in children under 6 years old)

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corps
FDA Application #
ANDA074352
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-17-1995
Listing Expiration
12-31-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17856-0618). Click a package code to view its specific billing and regulatory data.

17856-0618-1
10 mL in 1 CUP

* 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 17856-0618-5 identifies a specific commercial package of 5 ml in 1 cup of Loperamide Hydrochloride, labeled by Atlantic Biologicals Corps. 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 Atlantic Biologicals Corps on November 17, 1995. The current certification is valid through December 31, 2020.

How is this Atlantic Biologicals Corps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856061805. 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)
17856-0618-5
11-Digit CMS (5-4-2)
17856-0618-05

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