Keralyt
NDC Package 11086-043-06

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.

Keralyt is iNDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses. Marketed by Summers Laboratories Inc, this product is identified by NDC 11086-043.

Identification & Billing

NDC Package Code
11086-043-06
Package Description
160 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
11086-043
11-Digit Billing Format
11086004306
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
160 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Keralyt
Dosage Form
-
Usage Information
INDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.

Regulatory & Marketing

Labeler Name
Summers 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
11-01-2009
Listing Expiration
12-31-2024
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 11086-043-06 identifies a specific commercial package of 160 ml in 1 bottle, with applicator of Keralyt, labeled by Summers Laboratories Inc. This product is billed per "ML" milliliter and contains an estimated amount of 160 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 Summers Laboratories Inc on November 01, 2009. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11086004306. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 160 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 (5-3-2)
11086-043-06
11-Digit CMS (5-4-2)
11086-0043-06

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