Normosol-m And Dextrose Injection, Solution
NDC Package 0990-7965-09

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

Package Information

Normosol-m And Dextrose (dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate) injection is normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. This formulation utilizes a injection, solution delivery system. Marketed by Icu Medical Inc., this product is identified by NDC 0990-7965 and is authorized under FDA application NDA017610.

Identification & Billing

NDC Package Code
0990-7965-09
Package Description
12 POUCH in 1 CASE / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
Product Code
0990-7965
11-Digit Billing Format
00990796509
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 801005 - electrolyte-M in 5 % dextrose Injectable Solution
  • RxCUI: 801005 - glucose 50 MG/ML / magnesium acetate 0.000979 MEQ/ML / potassium acetate 0.013 MEQ/ML / sodium chloride 0.04 MEQ/ML Injectable Solution
  • RxCUI: 801005 - Glucose 50 MG/ML / magnesium acetate 0.000979 MEQ/ML / K+ Acetate 0.013 MEQ/ML / NaCl 0.04 MEQ/ML Injectable Solution
  • RxCUI: 801005 - Glucose 50 MG/ML / magnesium acetate 0.000979 MEQ/ML / Pot Acetate 0.013 MEQ/ML / NaCl 0.04 MEQ/ML Injectable Solution
  • RxCUI: 801009 - Normosol-M in 5 % Dextrose Injectable Solution

Clinical Specifications

Proprietary Name
Normosol-m And Dextrose
Non-Proprietary Name
Dextrose Monohydrate, Sodium Chloride, Potassium Acetate, And Magnesium Acetate
Substance Name
Dextrose Monohydrate; Magnesium Acetate; Potassium Acetate; Sodium Chloride
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-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.

Regulatory & Marketing

Labeler Name
Icu Medical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA017610
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-08-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0990-7965-09 identifies a specific commercial package of 12 pouch in 1 case / 1 bag in 1 pouch / 1000 ml in 1 bag of Normosol-m And Dextrose, a human prescription drug labeled by Icu Medical Inc.. This injection, solution is formulated for intravenous use and contains dextrose monohydrate; magnesium acetate; potassium acetate; 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 Icu Medical Inc. on February 08, 2021. 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: 00990796509. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0990-7965-09
11-Digit CMS (5-4-2)
00990-7965-09

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