NDC 24312-003 Nitrous Oxide
Gas Respiratory (inhalation)

Product Information

Nitrous Oxide is a human prescription drug product labeled by Airtec Gases, Llc. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Product Code24312-003
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
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.
Airtec Gases, Llc
Labeler Code24312
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA205704
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.
NDA - A product marketed under an approved New Drug Application.
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.
01-01-2004
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.
12-31-2023
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 24312-003-01

Package Description: 1477 L in 1 CYLINDER

Product Details

What are Nitrous Oxide Active Ingredients?

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.
  • NITROUS OXIDE 99 L/100L - Nitrogen oxide (N2O). A colorless, odorless gas that is used as an anesthetic and analgesic. High concentrations cause a narcotic effect and may replace oxygen, causing death by asphyxia. It is also used as a food aerosol in the preparation of whipping cream.

Nitrous Oxide Active Ingredients UNII Codes

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:

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Nitrous Oxide 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



Nitrous Oxide Usp Label



WARNING: DO NOT HANDLE CYLINDER OR USE CONTENTS UNTIL: 1) YOU HAVE READ AND UNDERSTAND THE MATERIAL SAFETY DATA SHEET FOR THIS PRODUCT. CALL YOUR SUPPLIER FOR MORE COPIES. 2) YOU ARE TRAINED TO USE CYLINDER AND CONTENTS, INCLUDING EMERGENCY PROCEDURES.

NITROUS OXIDE USP   UN 1070   RX ONLY   NON-FLAMMABLE 2   OXIDIZER 5.1

WARNING: HIGH PRESSURE, OXIDIZING LIQUID AND GAS. VIGOROUSLY ACCELERATES COMBUSTION. CAN CAUSE RAPID SUFFOCATION AND DEATH WITHOUT WARNING (DUE TO OXYGEN DEFICIENCY). CAN CAUSE ANESTHETIC EFFECTS. MAY CAUSE FROSTBITE. MAY CAUSE NERVOUS SYSTEM INJURY AND EMBRYO FETAL TOXICITY. Avoid breathing gas. Secure cylinder and provide adequate ventilation in storage and use. Keep oil and grease away. No smoking in cylinder area. Do not use or store near heat or open flame. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Do not get liquid in eyes, on skin or clothing. Cylinder temperature should not exceed 125° F (52° C). Open valve slowly. Close valve after each use and when empty. Return with at least 25 PSIG pressure. Use in accordance with Material Safety Data Sheet. NOTE: Suck-back into cylinder may cause rupture. Always use a back-flow preventive device in the piping.

FIRST AID: IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician. IN CASE OF FROSTBITE, obtain medical treatment immediatel

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 the precautions to e taken. CAUTION: Federal law prohibits dispensing without prescription.

CAUTION: USE NO OIL ON VALVE OR CONNECTIONS. TRANSFILLING OF THIS GAS IS PROHIBITED.

DO NOT REMOVE THIS PRODUCT LABEL

DISTRIBUTED BY:
AIRTEC GASES
LAS VEGAS, NV 89109
(702) 454-2400

ATG - 04


* Please review the disclaimer below.