NDC 74709-001 Oxygen
Gas Respiratory (inhalation)

Product Information

Product Code74709-001
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.
Oxygen
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.
Oxygen
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.
Air Liquide Canada Inc
Labeler Code74709
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.
05-01-2020
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 74709-001-01

Package Description: 18168 L in 1 TANK

Product Details

Oxygen is a human prescription drug product labeled by Air Liquide Canada Inc. The product's dosage form is gas and is administered via respiratory (inhalation) form.


What are Oxygen 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.

Oxygen 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



Air Liquide Canada Oxygen



Air Liquide

OXYGEN OXYGÈNÈ

COMPRESSED COMPRIMÈ

1072

2

DO NOT REMOVE THIS LABEL  OXYGEN / OXYGÈNÈ  NE PAS ENLEVER CETTE ÈTIQUETTE

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. 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 only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a backflow 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.

DANGER: PEUT PROVOQUER OU AGGRAVER UN INCENDIE: COMBURANT CONTENT DU GAZ SOUS PRESSION: PEUT EXPLOSER SOUS L’EFFET DE LA CHALEUR. No pas manipuler avant d’avoir lu et comprls toutes les precautions de sècuritè. Tenir à rècart des vètements et d’autres mabères combustibles. Tenir les soupapes et les accessoores exempt d’huile et de graisse. N’utiliser et n’entreposer qu’à l’extèrieur ou dans un endroit bien ventilè. EN CAS D’INCENDIE: Arrèter ta tuite si c’est possible sans danger. Poser un dispositive anti retour dans le circuit de conduits. Utilser uniquement avec l’equipement de matèriaux de construction compatibles et prèvu pour la pression de cylinder. Utilser uniquement avec l’èquipement nettoyè pour le service d’oxygène. Ouvrir lentement le robinet. Fermer le robinet apres chaque utilsation et torsque le contentant est vide. Protèger contre les rayons du soleit lorsque la temperature ambiante dèpasse 52°C (125° F). Lire et sulvre la Fiche Signaletique (FS) avant d’utiliser.

1-514-878-1667 AIR LIQUIDE Canada Inc. 1250 Renè-Levesque West, Suite 1700, Montreal, QC H3B 5E6 Canada


Air Liquide Canada Oxygen Coa



Consignor/ Expèditeur

Air Liquide                         Certificate of Analysis

                                        Certificat d’analyse

Plant Address                    Refrigerated Liquid / Liquide Réfrigéré

                                        Medical Oxygen / Oxygène Médical

                                                                                                           Date & Time

                                         Produced by Air Liquefaction  /  Fabriqué par Liquéfaction de l’air

                                         Meets current U.S.P. Specs / Rencontre la Spécifcation U.S.P.

Customer/Client: To be entered manually by the user when required

Lot Number / Numéro de LOT: __________________

Unit Number / Numéro de l’unité: _______________

Shipping Document / Document d’expédition: ________________

Componets /

Éléments

Specification /

Specification

Results /

Résultats

Uncertainty Limits /

Limite d’incertitude

Analysis method / Méthode d’analyse

Oxygen purity / Pureté Oxygène

>=99.0%

Analyzer Manufacturer:

Model:

Serial #:

Tag #:

Transportation Seal Numbers / Numéros des sceaux de Transport

Special Notes / Notes d’information:

ANALYSIS RESULTS /

RÉSULTATS D’ANALYSE

COMPLIES WITH REQUESTED SPECIFICATIONS / RENCONTRE

DOES NOT COMPLY WITH REQUESTED SPECIFICATIONS / NE

Filled By / Remplis par: Driver / Operator inputted by the system

Driver Signature / Signature du transporteur: ______________________________

Document Reviewed and Released By: ___________________________________

                                                                                                Printed Name

Document Revu et émis par:

                                ______________________________________________________

                                                                Signature

LI-32-506 rev 1 Medical Oxygen Certificate of Analysis


* Please review the disclaimer below.