Xacduro Kit
NDC Package 68547-111-10

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

Package Information

Xacduro (sulbactam and durlobactam) kits is xACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1)]. This formulation utilizes a kit delivery system. Marketed by La Jolla Pharmaceutical Company, this product is identified by NDC 68547-111 and is authorized under FDA application NDA216974.

Identification & Billing

NDC Package Code
68547-111-10
Package Description
1 KIT in 1 CARTON * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)
Product Code
68547-111
11-Digit Billing Format
68547011110
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xacduro
Non-Proprietary Name
Sulbactam And Durlobactam
Dosage Form
Kit - A packaged collection of related material.
Usage Information
XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
La Jolla Pharmaceutical Company
Product Type
Human Prescription Drug
FDA Application #
NDA216974
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-06-2023
Listing Expiration
12-31-2026
Exclude Flag
N
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 68547-111-10 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 vial, single-dose (68547-211-20) * 2.5 ml in 1 vial, single-dose (68547-311-30) of Xacduro, a human prescription drug labeled by La Jolla Pharmaceutical Company. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by La Jolla Pharmaceutical Company on June 06, 2023. The current certification is valid through December 31, 2026.

How is this La Jolla Pharmaceutical Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68547011110. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
68547-111-10
11-Digit CMS (5-4-2)
68547-0111-10

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