Loteprednol Etabonate Powder
NDC Package 55718-142-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Loteprednol Etabonate powders is a medication used to temporarily relieve seasonal allergy symptoms of the eyes such as swelling, redness, and itching. This formulation utilizes a powder delivery system. Marketed by Isomedix Operations Inc, this product is identified by NDC 55718-142.

Identification & Billing

NDC Package Code
55718-142-01
Package Description
250 g in 1 BAG
Product Code
55718-142
11-Digit Billing Format
55718014201

Clinical Specifications

Proprietary Name
Loteprednol Etabonate
Non-Proprietary Name
Loteprednol Etabonate
Substance Name
Loteprednol Etabonate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
LOTEPREDNOL ETABONATE 1 g/g
Usage Information
This medication is used to temporarily relieve seasonal allergy symptoms of the eyes such as swelling, redness, and itching. Loteprednol belongs to a class of drugs known as corticosteroids.

Regulatory & Marketing

Labeler Name
Isomedix Operations Inc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-14-2004
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 55718-142-01 identifies a specific commercial package of 250 g in 1 bag of Loteprednol Etabonate (UNFINISHED drug), drug for further processing labeled by Isomedix Operations Inc. This powder is formulated for use and contains loteprednol etabonate 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 Isomedix Operations Inc on December 14, 2004. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to temporarily relieve seasonal allergy symptoms of the eyes such as swelling, redness, and itching. Loteprednol belongs to a class of drugs known as corticosteroids.

How is this Isomedix Operations Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55718014201. 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)
55718-142-01
11-Digit CMS (5-4-2)
55718-0142-01

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