Keralyt
NDC Package 11086-048-99

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.

Keralyt is a . Marketed by Summers Laboratories Inc, this product is identified by NDC 11086-048.

Identification & Billing

NDC Package Code
11086-048-99
Package Description
1 KIT in 1 CELLO PACK * 20 mL in 1 BOTTLE, WITH APPLICATOR (11086-043-99) * 8 g in 1 TUBE (11086-030-99)
Product Code
11086-048
11-Digit Billing Format
11086004899

Clinical Specifications

Proprietary Name
Keralyt
Dosage Form
-

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
End Marketing Date
08-10-2015
Listing Expiration
08-10-2015
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 11086-048-99 identifies a specific commercial package of 1 kit in 1 cello pack * 20 ml in 1 bottle, with applicator (11086-043-99) * 8 g in 1 tube (11086-030-99) of Keralyt, labeled by Summers Laboratories Inc. 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 August 10, 2015.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11086004899. 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)
11086-048-99
11-Digit CMS (5-4-2)
11086-0048-99

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