Normosol-r Injection, Solution
NDC Package 0990-7670-03

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

Normosol-r (sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride) injection is normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. This formulation utilizes a injection, solution delivery system. Marketed by Icu Medical Inc., this product is identified by NDC 0990-7670 and is authorized under FDA application NDA017586.

Identification & Billing

NDC Package Code
0990-7670-03
Package Description
24 BAG in 1 CASE / 500 mL in 1 BAG
Product Code
0990-7670
11-Digit Billing Format
00990767003
RxNorm Crosswalk
  • RxCUI: 800985 - magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.0497 MEQ/ML / sodium acetate 0.0163 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution
  • RxCUI: 800985 - Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.0497 MEQ/ML / Sodium Acetate 0.0163 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution
  • RxCUI: 800985 - Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.0497 MEQ/ML / Sodium Acetate 0.0163 MEQ/ML / NaCl 0.0899 MEQ/ML / Sodium gluconate 5.02 MG/ML Injectable Solution
  • RxCUI: 800988 - NORMOSOL-R Injectable Solution
  • RxCUI: 800988 - magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.0497 MEQ/ML / sodium acetate 0.0163 MEQ/ML / sodium chloride 0.0899 MEQ/ML / sodium gluconate 5.02 MG/ML Injectable Solution [Normosol-R]

Clinical Specifications

Proprietary Name
Normosol-r
Non-Proprietary Name
Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, And Magnesium Chloride
Substance Name
Magnesium Chloride; Potassium Chloride; Sodium Acetate Anhydrous; Sodium Chloride; Sodium Gluconate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC.

Regulatory & Marketing

Labeler Name
Icu Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017586
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2019
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 (0990-7670). Click a package code to view its specific billing and regulatory data.

0990-7670-09
12 BAG in 1 CASE / 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 0990-7670-03 identifies a specific commercial package of 24 bag in 1 case / 500 ml in 1 bag of Normosol-r, a human prescription drug labeled by Icu Medical Inc.. This injection, solution is formulated for intravenous use and contains magnesium chloride; potassium chloride; sodium acetate anhydrous; sodium chloride; sodium gluconate 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 Icu Medical Inc. on September 01, 2019. The current certification is valid through December 31, 2026.

How is this Icu Medical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00990767003. 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 (4-4-2)
0990-7670-03
11-Digit CMS (5-4-2)
00990-7670-03

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