NDC 25373-703 Nitrous Oxide Sedara
Nitrous Oxide Gas Respiratory (inhalation)

Product Information

Product Code25373-703
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Nitrous Oxide Sedara
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Nitrous Oxide
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormGas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Linde Gas & Equipment Inc.
Labeler Code25373
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
UNAPPROVED MEDICAL GAS -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
06-18-2012
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Product Packages

NDC 25373-703-01

Package Description: 115 L in 1 CYLINDER

Product Details

Nitrous Oxide Sedara is a human prescription drug product labeled by Linde Gas & Equipment Inc.. The generic name of Nitrous Oxide Sedara is nitrous oxide. The product's dosage form is gas and is administered via respiratory (inhalation) form.


What are Nitrous Oxide Sedara Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


* Please review the disclaimer below.

Nitrous Oxide Sedara Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other Safety Information



FIRST AID: IF INHALED, Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER or doctor/physician if you feel unwell. IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
WARNING: This product contains a chemical known to the state of California to cause birth defects or other reproductive harm.  

RX ONLY
                                 
LPH040E
U.S. patent pending 


Package Label.Principal Display Panel



WARNING: Administration of Nitrous Oxide may be hazardous or contraindicated.  For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrous Oxide and is familiar with the indications, effects, dosages, methods and frequency and duration of administration, and with the hazards, contraindications and side effects, and precautions to be taken. 

DANGER:
MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY CAUSE DROWSINESS OR DIZZINESS. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. MAY CAUSE FROSTBITE. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Avoid breathing gas. Do not get in eyes, on skin, or on clothing. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.

THE LINDE GROUP 
LINDE 
Distributed by:
Linde Gas North America LLC
200 Somerset Corporate Blvd.
Suite 7000
Bridgewater, NJ 08807
866.543.3427

MEDICAL GAS 
For Use With SEDARA® Gas Mixer

NITROUS OXIDE                               
USP
UN 1070
CAS 10024-97-2
Content: 115 liters 
Do Not Remove this Label 

Batch Code
NON-FLAMMABLE GAS 2
OXIDIZER 5.1
!
Use in accordance with the Safety Data Sheet for this product. 


* Please review the disclaimer below.