NDC 44567-212-01 Ampicillin And Sulbactam
Injection, Powder, For Solution Intravenous

Package Information

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

Field Name	Field Value
NDC Package Code	44567-212-01
Package Description	1 VIAL in 1 CARTON / 100 mL in 1 VIAL
Product Code	44567-212
Proprietary Name What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.	Ampicillin And Sulbactam
Non-Proprietary Name What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.	Ampicillin And Sulbactam
Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.	Ampicillin Sodium; Sulbactam Sodium
Usage Information Product Usage Information The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.	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 NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.	44567021201
Billing Unit	EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Estimated Billable Units per Package	1 EA
NADAC Wholesale Price per Unit National Average Drug Acquisition Cost (NADAC) The National Average Drug Acquisition Cost (NADAC) wholesale price per unit for NDC 44567-212-01 is $24.63333 and is up-to-date as of 02-19-2014. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. The estimated wholesale price for the this package based on the lastest NADAC pricing survey is $24.63	$24.63333
Estimated Wholesale Price per Package	$24.63
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 What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.	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.
Active Ingredient(s)	AMPICILLIN SODIUM 10 g/100mL SULBACTAM SODIUM 5 g/100mL
Pharmacologic Class(es)	Penicillin-class Antibacterial - [EPC] (Established Pharmacologic Class) Penicillins - [CS] beta Lactamase Inhibitor - [EPC] (Established Pharmacologic Class) beta Lactamase Inhibitors - [MoA] (Mechanism of Action)
Sample Package Sample Package? This field Indicates whether this package is a sample packaging or not.	No
Marketing Category What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.	ANDA - A product marketed under an approved Abbreviated New Drug Application.
FDA Application Number What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.	ANDA065188
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	11-25-2005
Listing Expiration Date What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.	12-31-2023
Exclude Flag What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".	N
NDC Code Structure	44567 - Wg Critical Care, Llc 44567-212 - Ampicillin And Sulbactam 44567-212-01 - 1 VIAL in 1 CARTON / 100 mL in 1 VIAL

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.

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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 Code	HCPCS Code	HCPCS Code Desc.	Dosage	Package Size	Package Quantity	Billable Units	Billable Units / Pkg
44567021201	J0295	Ampicillin sulbactam 1.5 gm	1.5 GM	1	1	10	10

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