NDC 11054-152 Nitrogen Oxygen Mix

Nitrogen Oxygen Mix

NDC Product Code 11054-152

NDC 11054-152-01

Package Description: 402 L in 1 CYLINDER

NDC 11054-152-02

Package Description: 671 L in 1 CYLINDER

NDC 11054-152-03

Package Description: 6145 L in 1 CYLINDER

NDC 11054-152-04

Package Description: 399 L in 1 CYLINDER

NDC 11054-152-05

Package Description: 662 L in 1 CYLINDER

NDC 11054-152-06

Package Description: 6088 L in 1 CYLINDER

NDC Product Information

Nitrogen Oxygen Mix with NDC 11054-152 is a a human prescription drug product labeled by Airgas Usa, Llc. The generic name of Nitrogen Oxygen Mix is nitrogen oxygen mix. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Labeler Name: Airgas Usa, Llc

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.

Nitrogen Oxygen Mix 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.

  • OXYGEN 400 mL/L

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • NITROGEN (UNII: N762921K75)

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: Airgas Usa, Llc
Labeler Code: 11054
FDA Application Number: NDA206023 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: 02-01-2017 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: 12-31-2021 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".

* Please review the disclaimer below.

Nitrogen Oxygen Mix 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

Airgas 60% Nitrogen 40% Oxygen Mix

COMPRESSED GAS, OXIDIZING, N.O.S.(60% NITROGEN NF, 40% OXYGEN USP)UN3156NON-FLAMMABLE GAS 2              837136 (02/17)OXIDIZER 5.1WARNING: Rx only. Administration of this gas mixture may be hazardous or contraindicated. For use only or under the supervision of a licensed practioner who is experienced in the use and administration of gas mixtures, 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 be taken.DANGER: MAY CAUSE OR INTENSIDFY FIRE; OXIDZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. Use and store in 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 52OC (125OF). Read and follow the Safety Data Sheet (SDS) before use.CAS: OXYGEN 7782-44-7                NITROGEN 7727-37-9      DO NOT REMOVE THIS PRODUCT LABEL.Airgas, HealthcareAn Air Liquide companyAIRGAS USA, LLCRadnor, PA 19087-5283Safety Data Sheets available at www.airgas.com

Nitrogen/Oxygen Mix Un1956

COMPRESSED GAS, OXIDIZING, N.O.S.(___% NITROGEN NF, ___% OXYGEN USP)UN1956NON-FLAMMABLE GAS 2              837128 (02/17)WARNING: Rx only. Administration of this gas mixture may be hazardous or contraindicated. For use only or under the supervision of a licensed practioner who is experienced in the use and administration of gas mixtures, 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 be taken.DANGER: MAY CAUSE OR INTENSIDFY FIRE; OXIDZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. Use and store in 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 52OC (125OF). Read and follow the Safety Data Sheet (SDS) before use.CAS: OXYGEN 7782-44-7                NITROGEN 7727-37-9      FOR USE WITH RESPIRATORY CHALLENGE DIAGNOSTIC EQUIPMENT IN ACCORDANCE WITH MANUFACTURERS INSTRUCTIONS.DO NOT REMOVE THIS PRODUCT LABEL.Airgas, HealthcareAn Air Liquide companyAIRGAS USA, LLCRadnor, PA 19087-5283Safety Data Sheets available at www.airgas.com

Nitrogen/Oxygen Un3156

COMPRESSED GAS, OXIDIZING, N.O.S.(___% NITROGEN NF, ___% OXYGEN USP)UN3156NON-FLAMMABLE GAS 2              834428 (02/17)OXIDIZER 5.1OXYGEN CONTENT OVER 23.5%DANGER: MAY CAUSE OR INTENSIDFY FIRE; OXIDZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. Use and store in 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 52OC (125OF). Read and follow the Safety Data Sheet (SDS) before use.WARNING: Rx only. Administration of this gas mixture may be hazardous or contraindicated. For use only or under the supervision of a licensed practioner who is experienced in the use and administration of gas mixtures, 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 be taken.CAS: OXYGEN 7782-44-7                NITROGEN 7727-37-9      DO NOT REMOVE THIS PRODUCT LABEL.Airgas, HealthcareAn Air Liquide companyAIRGAS USA, LLCRadnor, PA 19087-5283Safety Data Sheets available at www.airgas.com

Nitrogen/Oxygen Un3156 - 2

COMPRESSED GAS, OXIDIZING, N.O.S.(___% NITROGEN NF, ___% OXYGEN USP)UN3156NON-FLAMMABLE GAS 2              834128 (02/17)OXIDIZER 5.1OXYGEN CONTENT OVER 23.5%Rx only.Caution: Federal law prohibits dispensing without prescription. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only or under the supervision of a licensed practioner who is experienced in the use and administration of gas mixtures, 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 be taken.DANGER: MAY CAUSE OR INTENSIDFY FIRE; OXIDZER, CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. 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. Use and store in 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 52OC (125OF). Read and follow the Safety Data Sheet (SDS) before use.CAS: NITROGEN 7727-37-9           OXYGEN 7782-44-7         Airgas, HealthcareAn Air Liquide companyAIRGAS USA, LLCRadnor, PA 19087-5283Safety Data Sheets available at www.airgas.com

* Please review the disclaimer below.