Keralyt
NDC Package 11086-052-55

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 11086-052 and is authorized under FDA application part358H.

Identification & Billing

NDC Package Code
11086-052-55
Package Description
1 BOTTLE in 1 BOX / 177 mL in 1 BOTTLE (11086-052-05)
Product Code
11086-052
11-Digit Billing Format
11086005255

Clinical Specifications

Proprietary Name
Keralyt
Dosage Form
-

Regulatory & Marketing

Labeler Name
Summers Laboratories Inc
FDA Application #
part358H
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-30-2013
End Marketing Date
10-26-2016
Listing Expiration
10-26-2016
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 11086-052-55 identifies a specific commercial package of 1 bottle in 1 box / 177 ml in 1 bottle (11086-052-05) 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 October 30, 2013. The current certification is valid through October 26, 2016.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11086005255. 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)
11086-052-55
11-Digit CMS (5-4-2)
11086-0052-55

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