Loperamide Hydrochloride Solution
NDC Package 17856-6836-2

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

Loperamide Hydrochloride (loperamide hcl) solution is see also Warning section. This formulation utilizes a solution delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-6836 and is authorized under FDA application ANDA091292.

Identification & Billing

NDC Package Code
17856-6836-2
Package Description
50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 15 mL in 1 CUP, UNIT-DOSE (17856-6836-4)
Product Code
17856-6836
11-Digit Billing Format
17856683602
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Non-Proprietary Name
Loperamide Hcl
Substance Name
Loperamide Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOPERAMIDE HYDROCHLORIDE 1 mg/7.5mL
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
Atlantic Biologicals Corp.
Product Type
Human Otc Drug
FDA Application #
ANDA091292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2018
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 (17856-6836). Click a package code to view its specific billing and regulatory data.

17856-6836-1
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 7.5 mL in 1 CUP, UNIT-DOSE (17856-6836-3)

* 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 17856-6836-2 identifies a specific commercial package of 50 cup, unit-dose in 1 box, unit-dose / 15 ml in 1 cup, unit-dose (17856-6836-4) of Loperamide Hydrochloride, a human over the counter drug labeled by Atlantic Biologicals Corp.. This solution 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 Atlantic Biologicals Corp. on November 29, 2018. 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 Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856683602. 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)
17856-6836-2
11-Digit CMS (5-4-2)
17856-6836-02

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