Xenleta
NDC Package 72000-110-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Xenleta is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Marketed by Nabriva Therapeutics Us, Inc., this product is identified by NDC 72000-110 and is authorized under FDA application NDA211672.

Identification & Billing

NDC Package Code
72000-110-10
Package Description
10 TABLET, COATED in 1 BLISTER PACK
Product Code
72000-110
11-Digit Billing Format
72000011010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xenleta
Dosage Form
-
Usage Information
XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Regulatory & Marketing

Labeler Name
Nabriva Therapeutics Us, Inc.
FDA Application #
NDA211672
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-09-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72000-110). Click a package code to view its specific billing and regulatory data.

72000-110-30
30 TABLET, COATED in 1 BOTTLE

* 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 72000-110-10 identifies a specific commercial package of 10 tablet, coated in 1 blister pack of Xenleta, labeled by Nabriva Therapeutics Us, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 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 Nabriva Therapeutics Us, Inc. on September 09, 2019. The current certification is valid through December 31, 2025.

How is this Nabriva Therapeutics Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72000011010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
72000-110-10
11-Digit CMS (5-4-2)
72000-0110-10

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