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  5. NDC Package Code: 68547-111-10 Xacduro

NDC Package 68547-111-10 Xacduro

Sulbactam And Durlobactam Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
Proprietary Name:
Xacduro
Non-Proprietary Name:
Sulbactam And Durlobactam
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)].
11-Digit NDC Billing Format:
68547011110
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2665012 - durlobactam 1 GM / sulbactam 1 GM Injection Kit
  • RxCUI: 2665012 - durlobactam 1000 MG / sulbactam 1000 MG Injection
  • RxCUI: 2665017 - XACDURO 1 GM / 1 GM Injection Kit
  • RxCUI: 2665017 - durlobactam 1000 MG / sulbactam 1000 MG Injection [Xacduro]
  • RxCUI: 2665017 - Xacduro 1 GM / 1 GM Injection Kit
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lajolla Pharmaceutical Company
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA216974
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-06-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 68547-111-10?

    The NDC Packaged Code 68547-111-10 is assigned to a 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 Lajolla Pharmaceutical Company. The product's dosage form is kit and is administered via form.

    Is NDC 68547-111 included in the NDC Directory?

    Yes, Xacduro with product code 68547-111 is active and included in the NDC Directory. The product was first marketed by Lajolla Pharmaceutical Company on June 06, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68547-111-10?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 68547-111-10?

    The 11-digit format is 68547011110. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268547-111-105-4-268547-0111-10