Anti-diarrheal Tablet
NDC Package 50844-375-45

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

Anti-diarrheal (loperamide hcl) tablets is see also Warning section. This formulation utilizes a tablet delivery system. Marketed by L.n.k. International, Inc., this product is identified by NDC 50844-375 and is authorized under FDA application ANDA076497.

Identification & Billing

NDC Package Code
50844-375-45
Package Description
1 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
Product Code
50844-375
11-Digit Billing Format
50844037545
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Anti-diarrheal
Non-Proprietary Name
Loperamide Hcl
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
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
L.n.k. International, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA076497
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-03-2005
Listing Expiration
12-31-2027
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 (50844-375). Click a package code to view its specific billing and regulatory data.

50844-375-02
3 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK
50844-375-08
4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK
50844-375-95
2 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

* 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 50844-375-45 identifies a specific commercial package of 1 blister pack in 1 carton / 6 tablet in 1 blister pack of Anti-diarrheal, a human over the counter drug labeled by L.n.k. International, 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 L.n.k. International, Inc. on May 03, 2005. The current certification is valid through December 31, 2027.

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 L.n.k. International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50844037545. 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)
50844-375-45
11-Digit CMS (5-4-2)
50844-0375-45

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