NDC Package 0990-7670-03 Normosol-r

Sodium Chloride,Sodium Acetate Anhydrous,Sodium Gluconate,Potassium Chloride,And Magnesium - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0990-7670-03
Package Description:
24 BAG in 1 CASE / 500 mL in 1 BAG
Product Code:
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
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.
11-Digit NDC Billing Format:
00990767003
NDC to 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]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Icu Medical Inc.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    NDA017586
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-01-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0990-7670-0912 BAG in 1 CASE / 1000 mL in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0990-7670-03?

    The NDC Packaged Code 0990-7670-03 is assigned to a package of 24 bag in 1 case / 500 ml in 1 bag of Normosol-r, a human prescription drug labeled by Icu Medical Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 0990-7670 included in the NDC Directory?

    Yes, Normosol-r with product code 0990-7670 is active and included in the NDC Directory. The product was first marketed by Icu Medical Inc. on September 01, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0990-7670-03?

    The 11-digit format is 00990767003. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20990-7670-035-4-200990-7670-03