NDC 22607-679 Piperacillin Sodium And Tazobactam Sodium

Injection, Powder, Lyophilized, For Solution - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
22607-679
Proprietary Name:
Piperacillin Sodium And Tazobactam Sodium
Non-Proprietary Name: [1]
Piperacillin Sodium And Tazobactam Sodium
Substance Name: [2]
Piperacillin Sodium; Tazobactam Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Labeler Name: [5]
Mitim S.r.l.
Labeler Code:
22607
Marketing Category: [8]
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date: [9]
03-20-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure:
Code Navigator:

Product Packages

NDC Code 22607-679-01

Package Description: 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON / 180 mL in 1 VIAL, PHARMACY BULK PACKAGE (22607-679-02)

Product Details

What is NDC 22607-679?

The NDC code 22607-679 is assigned by the FDA to the UNFINISHED product Piperacillin Sodium And Tazobactam Sodium which is a human prescription drug product labeled by Mitim S.r.l.. The generic name of Piperacillin Sodium And Tazobactam Sodium is piperacillin sodium and tazobactam sodium. The product's dosage form is injection, powder, lyophilized, for solution. The product is distributed in a single package with assigned NDC code 22607-679-01 1 vial, pharmacy bulk package in 1 carton / 180 ml in 1 vial, pharmacy bulk package (22607-679-02). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Piperacillin Sodium And Tazobactam Sodium?

Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus. The individual members of this group were studied in fewer than 10 cases.

What are Piperacillin Sodium And Tazobactam Sodium Active Ingredients?

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.
  • PIPERACILLIN SODIUM 36 g/180mL - Semisynthetic, broad-spectrum, AMPICILLIN derived ureidopenicillin antibiotic proposed for PSEUDOMONAS infections. It is also used in combination with other antibiotics.
  • TAZOBACTAM SODIUM 4.5 g/180mL - A penicillanic acid and sulfone derivative and potent BETA-LACTAMASE inhibitor that enhances the activity of other anti-bacterial agents against beta-lactamase producing bacteria.

Which are Piperacillin Sodium And Tazobactam Sodium UNII Codes?

The UNII codes for the active ingredients in this product are:

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Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] 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.

[9] 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] 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] 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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.