Loperamide Hydrochloride
NDC Package 53329-664-57

11-digit billing NDC: 53329066457
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 discontinued by the firm.

Loperamide Hydrochloride is drink plenty of clear fluids to help prevent dehydration caused by diarrheafind right dose on chart. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-664 and is authorized under FDA application ANDA074091.

Identification & Billing

NDC Package Code
53329-664-57
Package Description
12 TABLET in 1 BLISTER PACK
Product Code
53329-664
11-Digit Billing Format
53329066457

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 over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 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 hours children 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 hours children under 6 years (up to 47 lbs) ask a doctor

Regulatory & Marketing

Labeler Name
Medline Industries, Lp
FDA Application #
ANDA074091
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-1993
End Marketing Date
01-31-2025
Listing Expiration
01-31-2025
Exclude Flag
D
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 53329-664-57 identifies a specific commercial package of 12 tablet in 1 blister pack of Loperamide Hydrochloride, labeled by Medline Industries, Lp. 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 Medline Industries, Lp on February 01, 1993. The current certification is valid through January 31, 2025.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329066457. 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)
53329-664-57
11-Digit CMS (5-4-2)
53329-0664-57

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