NDC Package 36000-094-10 Ampicillin And Sulbactam

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

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:
36000-094-10
Package Description:
10 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Product Code:
Proprietary Name:
Ampicillin And Sulbactam
Usage Information:
Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus,Escherichia coli,2 Klebsiella spp.2 (including K. pneumoniae2), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2NOTE: For information on use in pediatric patients see PRECAUTIONS – Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae2), Bacteroides spp. (including B. fragilis), and Enterobacter spp.2Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2 and Bacteroides spp.2 (including B. fragilis2).__________2Efficacy for this microorganism in this organ system was studied in fewer than 10 infections.While Ampicillin and Sulbactam for Injection USP is indicated only for the conditions listed above, infections caused by ampicillin susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection USP should not require the addition of another antibacterial.Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam.Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam and other antibacterial drugs, Ampicillin and Sulbactam for Injection USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
11-Digit NDC Billing Format:
36000009410
NDC to RxNorm Crosswalk:
  • RxCUI: 1659592 - ampicillin / sulbactam 1.5 GM Injection
  • RxCUI: 1659592 - ampicillin 1000 MG / sulbactam 500 MG Injection
  • RxCUI: 1659592 - ampicillin (as ampicillin sodium) 1 GM / sulbactam (as sulbactam sodium) 0.5 GM Injection
  • RxCUI: 1659592 - ampicillin 1 GM / sulbactam 0.5 GM Injection
  • RxCUI: 1659598 - ampicillin / sulbactam 3 GM Injection
  • Labeler Name:
    Claris Life Sciences Inc.
    Sample Package:
    No
    Start Marketing Date:
    12-14-2015
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    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 36000-094-10?

    The NDC Packaged Code 36000-094-10 is assigned to a package of 10 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass of Ampicillin And Sulbactam, labeled by Claris Life Sciences Inc.. The product's dosage form is and is administered via form.

    Is NDC 36000-094 included in the NDC Directory?

    No, Ampicillin And Sulbactam with product code 36000-094 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Claris Life Sciences Inc. on December 14, 2015 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 36000-094-10?

    The 11-digit format is 36000009410. 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
    5-3-236000-094-105-4-236000-0094-10