40% Oxygen/nitrogen Mix Gas
NDC Package 12213-200-01

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

Package Information

40% Oxygen/nitrogen Mix gases is a human prescription drug administered via respiratory (inhalation) route. This formulation utilizes a gas delivery system. Marketed by Nexair Llc, this product is identified by NDC 12213-200 and is authorized under FDA application NDA205865.

Identification & Billing

NDC Package Code
12213-200-01
Package Description
5984 L in 1 CYLINDER
Product Code
12213-200
11-Digit Billing Format
12213020001
RxNorm Crosswalk
RxCUI: 348544 - nitrogen 60 % / oxygen 40 % Gas for Inhalation

Clinical Specifications

Proprietary Name
40% Oxygen/nitrogen Mix
Non-Proprietary Name
40% Oxygen/nitrogen Mix
Substance Name
Oxygen
Dosage Form
Gas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
OXYGEN 400 mL/L

Regulatory & Marketing

Labeler Name
Nexair Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205865
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-09-2020
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 12213-200-01 identifies a specific commercial package of 5984 l in 1 cylinder of 40% Oxygen/nitrogen Mix, a human prescription drug labeled by Nexair Llc. This gas is formulated for respiratory (inhalation) use and contains oxygen 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 Nexair Llc on April 09, 2020. The current certification is valid through December 31, 2026.

How is this Nexair Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12213020001. 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 (5-3-2)
12213-200-01
11-Digit CMS (5-4-2)
12213-0200-01

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