Lotilaner Tablet, Chewable
NDC Package 58198-4521-1

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.

Lotilaner tablets is a drug for further processing. This formulation utilizes a tablet, chewable delivery system. Marketed by Elanco Us Inc., this product is identified by NDC 58198-4521.

Identification & Billing

NDC Package Code
58198-4521-1
Package Description
1 BAG in 1 DRUM / 81500 TABLET, CHEWABLE in 1 BAG
Product Code
58198-4521
11-Digit Billing Format
58198452101

Clinical Specifications

Proprietary Name
Lotilaner
Non-Proprietary Name
Lotilaner
Substance Name
Lotilaner
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Active Ingredient(s)
LOTILANER 56.25 mg/1

Regulatory & Marketing

Labeler Name
Elanco Us 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
01-19-2018
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 58198-4521-1 identifies a specific commercial package of 1 bag in 1 drum / 81500 tablet, chewable in 1 bag of Lotilaner (UNFINISHED drug), drug for further processing labeled by Elanco Us Inc.. This tablet, chewable is formulated for use and contains lotilaner 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 Elanco Us Inc. on January 19, 2018. The current certification is valid through December 31, 2026.

How is this Elanco Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58198452101. 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 (5-4-1)
58198-4521-1
11-Digit CMS (5-4-2)
58198-4521-01

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