Genosyl Gas
NDC Package 72385-003-01

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

Package Information

Genosyl (nitric oxide) gases is gENOSYL ®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 Vero Biotech, Inc., this product is identified by NDC 72385-003 and is authorized under FDA application NDA202860.

Identification & Billing

NDC Package Code
72385-003-01
Package Description
73 L in 1 CARTRIDGE
Product Code
72385-003
11-Digit Billing Format
72385000301

Clinical Specifications

Proprietary Name
Genosyl
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
GENOSYL ®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
Vero Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA202860
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-04-2025
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 72385-003-01 identifies a specific commercial package of 73 l in 1 cartridge of Genosyl, a human prescription drug labeled by Vero Biotech, Inc.. 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 Vero Biotech, Inc. on June 04, 2025. The current certification is valid through December 31, 2026.

How is this Vero Biotech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72385000301. 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)
72385-003-01
11-Digit CMS (5-4-2)
72385-0003-01

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