Loperamide Hydrochloride
NDC Package 0363-0645-34

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 discontinued by the firm.

Loperamide Hydrochloride is a . Marketed by Walgreen Company, this product is identified by NDC 0363-0645 and is authorized under FDA application ANDA091292.

Identification & Billing

NDC Package Code
0363-0645-34
Package Description
240 mL in 1 BOTTLE
Product Code
0363-0645
11-Digit Billing Format
00363064534
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Walgreen Company
FDA Application #
ANDA091292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-18-2012
End Marketing Date
12-31-2023
Listing Expiration
12-31-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0363-0645). Click a package code to view its specific billing and regulatory data.

0363-0645-26
120 mL in 1 BOTTLE

* 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 0363-0645-34 identifies a specific commercial package of 240 ml in 1 bottle of Loperamide Hydrochloride, labeled by Walgreen Company. This product is billed per "ML" milliliter and contains an estimated amount of 240 billable units per package. 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 Walgreen Company on May 18, 2012. The current certification is valid through December 31, 2023.

How is this Walgreen Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363064534. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 total billable units per package. 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 (4-4-2)
0363-0645-34
11-Digit CMS (5-4-2)
00363-0645-34

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