Turkfleks Lactated Ringer Solution
NDC 85160-500

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 85160-500?
  4. Turkfleks Lactated Ringer Solution Uses
  5. Active Ingredients UNII Codes

Product Information

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

Turkfleks Lactated Ringer Solution is a UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE-approved product labeled by Turk Ilac Ve Serum Sanayi. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 85160-500 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85160-500
Proprietary Name:
Turkfleks Lactated Ringer Solution
Product Type: [3]
EXPIRED PRODUCT and EXCLUDED from the NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Turk Ilac Ve Serum Sanayi
Labeler Code:
85160
Product Label ID:
31d5a70d-d1fd-a5cd-e063-6394a90ac2f9
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 85160-500?

The NDC code 85160-500 is assigned by the FDA to the product Turkfleks Lactated Ringer Solution. This pharmaceutical product is labeled by Turk Ilac Ve Serum Sanayi and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 85160-500-10, 85160-500-20. 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?

• Patients with known hypersensitivity to sodium lactate • Extracellular hyperhydration or hypervolemia • Severe renal failure (with oliguria/anuria) • Decompensated heart failure • Hyperkalemia • Hypercalcemia • Metabolic alkalosis • Cirrhosis with ascites • Severe metabolic acidosis • Conditions with increased lactate levels (hyperlactatemia), including conditions in which lactate utilization is impaired, such as lactic acidosis or severe hepatic failure • Use with digitalis therapy (See 4.5. Interactions with other medicinal products and other forms of interaction) • In newborn infants under 28 days of age, the use of TURKFLEKS LACTATED RINGER, like other calcium-containing solutions, with ceftriaxone is contraindicated, even if administered through separate infusion lines (due to fatal ceftriaxone calcium salt precipitation in the newborn's bloodstream). For the use of TURKFLEKS LACTATED RINGER with ceftriaxone in patients older than 28 days, see section '4.4. Special warnings and precautions for use'.

Which are the associated UNII Codes?

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

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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".