Turkfleks 0.9% Isotonic Sodium Chloride Solution
NDC 85160-400

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 85160-400?
  4. Turkfleks 0.9% Isotonic Sodium Chloride Solution Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk

Product Information

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

Turkfleks 0.9% Isotonic Sodium Chloride Solution is a EMERGENCY USE AUTHORIZATION-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 85160-400 and 7 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85160-400
Proprietary Name:
Turkfleks 0.9% Isotonic Sodium Chloride 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:
31d4876a-87c3-c0ab-e063-6294a90ada57
Marketing Category: [8]
EMERGENCY USE AUTHORIZATION

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 85160-400?

The NDC code 85160-400 is assigned by the FDA to the product Turkfleks 0.9% Isotonic Sodium Chloride 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 7 different package configurations. 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?

Therapeutic indications TURKFLEKS 0.9% ISOTONIC SODIUM CHLORIDE is indicated for: - Treatment of isotonic extracellular dehydration - Treatment of sodium depletion - As diluent of compatible drugs for parenteral administration.

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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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".