1. Home
  2. Labeler Index
  3. Allecra Therapeutics Sas
  4. 83289-101
  5. NDC Package Code: 83289-101-02 Exblifep

NDC Package 83289-101-02 Exblifep

Cefepime Hydrochloride,Enmetazobactam Injection, Powder, For Solution Intravenous - 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:
83289-101-02
Package Description:
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code:
83289-101
Proprietary Name:
Exblifep
Non-Proprietary Name:
Cefepime Hydrochloride, Enmetazobactam
Substance Name:
Cefepime Hydrochloride; Enmetazobactam
Usage Information:
EXBLIFEP is contraindicated in patients with a history of serious hypersensitivity reactions to the components of EXBLIFEP (cefepime and enmetazobactam) or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1)].
11-Digit NDC Billing Format:
83289010102
NDC to RxNorm Crosswalk:
  • RxCUI: 2675990 - cefepime / enmetazobactam 2.5 GM Injection
  • RxCUI: 2675990 - cefepime 2000 MG / enmetazobactam 500 MG Injection
  • RxCUI: 2675995 - EXBLIFEP 2.5 GM Injection
  • RxCUI: 2675995 - cefepime 2000 MG / enmetazobactam 500 MG Injection [Exblifep]
  • RxCUI: 2675995 - Exblifep (cefepime / enmetazobactam) 2.5 GM Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Allecra Therapeutics Sas
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • CEFEPIME HYDROCHLORIDE 2 g/1
  • ENMETAZOBACTAM .5 g/1
    • Pharmacologic Class(es):
  • Cephalosporin Antibacterial - [EPC] (Established Pharmacologic Class)
  • Cephalosporins - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA216165
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-28-2024
    Listing Expiration Date:
    12-31-2025
    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 83289-101-02?

    The NDC Packaged Code 83289-101-02 is assigned to a package of 10 vial, single-dose in 1 carton / 1 injection, powder, for solution in 1 vial, single-dose of Exblifep, a human prescription drug labeled by Allecra Therapeutics Sas. The product's dosage form is injection, powder, for solution and is administered via intravenous form.

    Is NDC 83289-101 included in the NDC Directory?

    Yes, Exblifep with product code 83289-101 is active and included in the NDC Directory. The product was first marketed by Allecra Therapeutics Sas on February 28, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83289-101-02?

    The 11-digit format is 83289010102. 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
    5-3-283289-101-025-4-283289-0101-02