Inomax Gas
NDC Package 64693-002-01

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

Inomax (nitric oxide) gases is iNOmax® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. This formulation utilizes a gas delivery system. Marketed by Ino Therapeutics Llc, this product is identified by NDC 64693-002 and is authorized under FDA application NDA020845.

Identification & Billing

NDC Package Code
64693-002-01
Package Description
1 CYLINDER in 1 CARTON / 353 L in 1 CYLINDER
Product Code
64693-002
11-Digit Billing Format
64693000201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Inomax
Non-Proprietary Name
Nitric Oxide
Substance Name
Nitric Oxide
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)
NITRIC OXIDE .98 mg/L
Pharmacologic Class
Usage Information
INOmax® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Regulatory & Marketing

Labeler Name
Ino Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020845
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-1999
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 (64693-002). Click a package code to view its specific billing and regulatory data.

64693-002-02
1 CYLINDER in 1 CARTON / 1963 L in 1 CYLINDER

* 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 64693-002-01 identifies a specific commercial package of 1 cylinder in 1 carton / 353 l in 1 cylinder of Inomax, a human prescription drug labeled by Ino Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This gas is formulated for respiratory (inhalation) use and contains nitric oxide 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 Ino Therapeutics Llc on December 23, 1999. The current certification is valid through December 31, 2026.

How is this Ino Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64693000201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
64693-002-01
11-Digit CMS (5-4-2)
64693-0002-01

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