Gadavyt Loperamide Hcl
NDC Package 53113-657-04

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.

Gadavyt Loperamide Hcl is usescontrols the symptoms of diarrhea, including Traveler's Diarrhea. Marketed by Gadal Laboratories Inc, this product is identified by NDC 53113-657.

Identification & Billing

NDC Package Code
53113-657-04
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
53113-657
11-Digit Billing Format
53113065704
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gadavyt Loperamide Hcl
Dosage Form
-
Usage Information
Usescontrols the symptoms of diarrhea, including Traveler's Diarrhea.

Regulatory & Marketing

Labeler Name
Gadal Laboratories Inc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-01-2013
Listing Expiration
12-31-2017
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 53113-657-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Gadavyt Loperamide Hcl, labeled by Gadal Laboratories Inc. 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 Gadal Laboratories Inc on May 01, 2013. The current certification is valid through December 31, 2017.

How is this Gadal Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53113065704. 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)
53113-657-04
11-Digit CMS (5-4-2)
53113-0657-04

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