Xeglyze
NDC Package 43598-921-11

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.

Xeglyze is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-921 and is authorized under FDA application NDA206966.

Identification & Billing

NDC Package Code
43598-921-11
Package Description
1 BOTTLE in 1 CARTON / 200 g in 1 BOTTLE
Product Code
43598-921
11-Digit Billing Format
43598092111
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xeglyze
Dosage Form
-
Usage Information
XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program:Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towelsWash personal care items such as combs, brushes, and hair clips in hot waterUse a fine-tooth comb or special nit comb to remove dead lice and nits

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
FDA Application #
NDA206966
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-29-2021
Listing Expiration
12-31-2025
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 43598-921-11 identifies a specific commercial package of 1 bottle in 1 carton / 200 g in 1 bottle of Xeglyze, labeled by Dr. Reddy's 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 Dr. Reddy's Laboratories Inc. on January 29, 2021. The current certification is valid through December 31, 2025.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598092111. 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)
43598-921-11
11-Digit CMS (5-4-2)
43598-0921-11

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