NDC 44567-104-01 Ampicillin
Injection, Powder, For Solution Intravenous
NDC Package Code 44567-104-01
The NDC Code 44567-104-01 is assigned to a package of 1 vial in 1 carton > 100 ml in 1 vial of Ampicillin, 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.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.
| Field Name | Field Value |
|---|---|
| NDC Code | 44567-104-01 |
| Package Description | 1 VIAL in 1 CARTON > 100 mL in 1 VIAL |
| Product Code | 44567-104 |
| Proprietary Name | Ampicillin 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. |
| Non-Proprietary Name | Ampicillin 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. |
| Drug Uses | Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by S. pneumoniae, Staphylococcus aureus (penicillinase and non-penicillinase producing), H. influenzae and Group A beta-hemolytic streptococci.Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness againstGram-negative bacteria.Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin-G-susceptible staphylococci and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis.Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp. and Shigella spp. (dysentery) usually respond to oral or intravenous therapy.Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibilty testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. Indicated surgical procedures should be performed. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin 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 | 44567010401 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. |
| Billing Unit | EA - Billing unit of "each" is used when the product is dispensed in discreet units. |
| Estimated Billable Units per Package | 1 EA |
| RxNorm Crosswalk | |
| Product Type | Human Prescription Drug 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. |
| 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) |
|
| Active Ingredient(s) | |
| Pharmacologic Class(es) | |
| Sample Package | No Sample Package? This field Indicates whether this package is a sample packaging or not. |
| Marketing Category | ANDA - A product marketed under an approved Abbreviated New Drug Application. 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. |
| FDA Application Number | ANDA063142 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. |
| Start Marketing Date | 05-10-2012 What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Listing Expiration Date | 12-31-2022 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. |
| Exclude Flag | N 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". |
NDC Code Structure
- 44567 - Wg Critical Care, Llc
- 44567-104 - Ampicillin
- 44567-104-01 - 1 VIAL in 1 CARTON
- 44567-104 - Ampicillin
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 44567-104-01 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 |
|---|---|---|---|---|---|---|---|
| 44567010401 | J0290 | Ampicillin 500 mg inj | 500 MG | 1 | 1 | 20 | 20 |
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Other Product Packages
The following packages are also available for Ampicillin with product NDC 44567-104.
| NDC Package Code | Package Description |
|---|---|
| 44567-104-10 | 10 VIAL in 1 TRAY > 100 mL in 1 VIAL |
* Please review the disclaimer below.