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  5. NDC Package Code: 72385-001-01 Genosyl

NDC Package 72385-001-01 Genosyl

Nitric Oxide Gas Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
72385-001-01
Package Description:
216 L in 1 CARTRIDGE
Product Code:
72385-001
Proprietary Name:
Genosyl
Non-Proprietary Name:
Nitric Oxide
Substance Name:
Nitric Oxide
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.
11-Digit NDC Billing Format:
72385000101
Product Type:
Human Prescription Drug
Labeler Name:
Vero Biotech, Inc.
Dosage Form:
Gas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.
Administration Route(s):
  • 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(es):
  • Vasodilation - [PE] (Physiologic Effect)
  • Vasodilator - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA202860
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-20-2019
    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.

    Frequently Asked Questions

    What is NDC 72385-001-01?

    The NDC Packaged Code 72385-001-01 is assigned to a package of 216 l in 1 cartridge of Genosyl, a human prescription drug labeled by Vero Biotech, Inc.. The product's dosage form is gas and is administered via respiratory (inhalation) form.

    Is NDC 72385-001 included in the NDC Directory?

    Yes, Genosyl with product code 72385-001 is active and included in the NDC Directory. The product was first marketed by Vero Biotech, Inc. on December 20, 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 72385-001-01?

    The 11-digit format is 72385000101. 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 5-3-2 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
    5-3-272385-001-015-4-272385-0001-01