Loperamide Hydrochloride
NDC Package 0054-8535-16

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 discontinued by the firm.

Loperamide Hydrochloride is a . Marketed by Roxane Laboratories, Inc, this product is identified by NDC 0054-8535 and is authorized under FDA application ANDA073079.

Identification & Billing

NDC Package Code
0054-8535-16
Package Description
10 mL in 1 CUP, UNIT-DOSE
Product Code
0054-8535
11-Digit Billing Format
00054853516
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML

Clinical Specifications

Proprietary Name
Loperamide Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Roxane Laboratories, Inc
FDA Application #
ANDA073079
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-1992
End Marketing Date
07-18-2011
Listing Expiration
07-18-2011
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 0054-8535-16 identifies a specific commercial package of 10 ml in 1 cup, unit-dose of Loperamide Hydrochloride, labeled by Roxane Laboratories, Inc. This product is billed per "ML" milliliter and contains an estimated amount of 10 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 Roxane Laboratories, Inc on April 30, 1992. The current certification is valid through July 18, 2011.

How is this Roxane Laboratories, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054853516. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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)
0054-8535-16
11-Digit CMS (5-4-2)
00054-8535-16

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