NDC 24312-003 Nitrous Oxide

Nitrous Oxide

NDC Product Code 24312-003

NDC 24312-003-01

Package Description: 1477 L in 1 CYLINDER

NDC Product Information

Nitrous Oxide with NDC 24312-003 is a a human prescription drug product labeled by Airtec Gases, Llc. The generic name of Nitrous Oxide is nitrous oxide. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Dosage Form: Gas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.

Product Type: Human Prescription Drug 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.

Nitrous Oxide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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.

Labeler Name: Airtec Gases, Llc
Labeler Code: 24312
FDA Application Number: NDA205704 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 01-01-2004 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

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Nitrous Oxide Product Label Images

Nitrous Oxide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 5.1WARNING: 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 immediatelWARNING: 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 LABELDISTRIBUTED BY:AIRTEC GASESLAS VEGAS, NV 89109(702) 454-2400ATG - 04

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