Turkfleks %0.5 Metronidazole Infusion Solution
NDC 85160-100

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

Turkfleks %0.5 Metronidazole Infusion Solution is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Turk Ilac Ve Serum Sanayi Anonim Sirketi. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 85160-100 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85160-100
Proprietary Name:
Turkfleks %0.5 Metronidazole Infusion Solution
Product Type: [3]
EXPIRED PRODUCT and EXCLUDED from the NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Code:
85160
Marketing Category: [8]
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

Marketing Timeline

Start Marketing Date: [9]
01-15-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
E

Code Structure Chart

Product Details

What is NDC 85160-100?

The NDC code 85160-100 is assigned by the FDA to the product Turkfleks %0.5 Metronidazole Infusion Solution. This pharmaceutical product is labeled by Turk Ilac Ve Serum Sanayi Anonim Sirketi and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 85160-100-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Medical and surgical infections caused by anaerobic bacteria sensitive to metronidazole in the treatment of infections, For prophylactic purposes in surgical procedures with a risk of anaerobic infection development, It is indicated in severe intestinal and hepatic amebiasis.

Which are the associated UNII Codes?

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

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Metronidazole Injection


Metronidazole injection is used to treat certain skin, blood, bone, joint, gynecologic, and abdominal (stomach area) infections caused by bacteria. It is also used to treat endocarditis (infection of the heart lining and valves), meningitis (infection of the membranes that surround the brain and spinal cord), and certain respiratory infections, including pneumonia. Metronidazole injection is also to prevent infection when used before, during, and after colorectal surgery. Metronidazole injection is in a class of medications called antibacterials. It works by killing bacteria and protozoa that cause infection. Antibiotics such as metronidazole injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.infections of the respiratory tract, including bronchitis, pneumonia
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".