Isotonic Sodium Chloride Injection
NDC Package 85184-0001-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Isotonic Sodium Chloride (biofleks isotonic sodium chloride sterile) injection is a medication used to treat dryness inside the nose (nasal passages). This formulation utilizes a injection delivery system. Marketed by Haver Farma Ilac Anonim Sirketi, this product is identified by NDC 85184-0001.

Identification & Billing

NDC Package Code
85184-0001-2
Package Description
250 mL in 1 BAG
Product Code
85184-0001
11-Digit Billing Format
85184000102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isotonic Sodium Chloride
Non-Proprietary Name
Biofleks Isotonic Sodium Chloride Sterile
Substance Name
Sodium Chloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Irrigation - Administration to bathe or flush open wounds or body cavities.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SODIUM CHLORIDE .9 g/100mL
Usage Information
This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

Regulatory & Marketing

Labeler Name
Haver Farma Ilac Anonim Sirketi
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (85184-0001). Click a package code to view its specific billing and regulatory data.

85184-0001-1
100 mL in 1 BAG
85184-0001-3
500 mL in 1 BAG
85184-0001-4
1000 mL in 1 BAG

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 85184-0001-2 identifies a specific commercial package of 250 ml in 1 bag of Isotonic Sodium Chloride, a human prescription drug labeled by Haver Farma Ilac Anonim Sirketi. This injection is formulated for intramuscular; intravenous; irrigation; subcutaneous use and contains sodium chloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Haver Farma Ilac Anonim Sirketi on January 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

How is this Haver Farma Ilac Anonim Sirketi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85184000102. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
85184-0001-2
11-Digit CMS (5-4-2)
85184-0001-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.