NDC Package 44567-212-01 Ampicillin And Sulbactam

Injection, Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
44567-212-01
Package Description:
1 VIAL in 1 CARTON / 100 mL in 1 VIAL
Product Code:
Proprietary Name:
Ampicillin And Sulbactam
Non-Proprietary Name:
Ampicillin And Sulbactam
Substance Name:
Ampicillin Sodium; Sulbactam Sodium
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 ofStaphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*),Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* an Acinetobactercalcoaceticus.*NOTE: 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 Escherichiacoli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*Gynecological Infections caused by beta-lactamase producing strains of Escherichiacoli,* and Bacteroides spp.* (including B. fragilis*).* Efficacy for this organism 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 for Injection, USP.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 the effectiveness of Ampicillin and Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin and Sulbactam for Injection, USP should be used only to treat or prevent 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:
44567021201
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 240984 - ampicillin 100 MG / sulbactam 50 MG per ML Injectable Solution
  • RxCUI: 240984 - ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution
  • RxCUI: 240984 - ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution
  • RxCUI: 240984 - ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Wg Critical Care, Llc
    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.
  • Sample Package:
    No
    FDA Application Number:
    ANDA065188
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-25-2005
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 44567-212-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    44567021201J0295Ampicillin sulbactam 1.5 gm1.5 GM111010

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 44567-212-01?

    The NDC Packaged Code 44567-212-01 is assigned to a package of 1 vial in 1 carton / 100 ml in 1 vial of Ampicillin And Sulbactam, a human prescription drug labeled by Wg Critical Care, Llc. The product's dosage form is injection, powder, for solution and is administered via intravenous form.

    Is NDC 44567-212 included in the NDC Directory?

    Yes, Ampicillin And Sulbactam with product code 44567-212 is active and included in the NDC Directory. The product was first marketed by Wg Critical Care, Llc on November 25, 2005 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 44567-212-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 44567-212-01?

    The 11-digit format is 44567021201. 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
    5-3-244567-212-015-4-244567-0212-01