Oxygen
Air Liquide Canada Inc
Human Prescription Drug
NDC 74709-001Oxygen is a human prescription drug labeled by 'Air Liquide Canada Inc'. National Drug Code (NDC) number for Oxygen is 74709-001. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Oxygen drug includes Oxygen - 992 mL/L . The currest status of Oxygen drug is Active.
Drug Information:
| Drug NDC: | 74709-001 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Oxygen |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Oxygen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Air Liquide Canada Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gas |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | OXYGEN - 992 mL/L
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED MEDICAL GAS |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Air Liquide Canada Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 348831
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | S88TT14065
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 74709-001-01 | 18168 L in 1 TANK (74709-001-01) | 01 May, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Oxygen oxygen oxygen oxygen
Package Label Principal Display Panel:
Air liquide canada oxygen air liquide oxygen oxygÃnà compressed comprimà 1072 2 do not remove this label oxygen / oxygÃnà ne pas enlever cette Ãtiquette 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 lâeffet de la chaleur. no pas manipuler avant dâavoir lu et comprls toutes les precautions de sècuritè. tenir à rècart des vètements et dâautres mabères combustibles. tenir les soupapes et les accessoores exempt dâhuile et de graisse. nâutiliser et nâentreposer quâà lâextèrieur ou dans un endroit bien ventilè. en cas dâincendie: arrèter ta tuite si câest possible sans danger. poser un dispositive anti retour dans le circuit de conduits. utilser uniquement avec lâequipement de matèriaux de construction compatibles et prèvu pour la pression de cylinder. utilser uniquement avec lâèquipement nettoyè pour le service dâoxygène. 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 dâutiliser. 1-514-878-1667 air liquide canada inc. 1250 renè-levesque west, suite 1700, montreal, qc h3b 5e6 canada air liquide oxygen
Air liquide canada oxygen coa consignor/ expèditeur air liquide certificate of analysis certificat dâanalyse plant address refrigerated liquid / liquide réfrigéré medical oxygen / oxygène médical date & time produced by air liquefaction / fabriqué par liquéfaction de lâair 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 lâunité: _______________ shipping document / document dâexpédition: ________________ componets / Ãléments specification / specification results / résultats uncertainty limits / limite dâincertitude analysis method / méthode dâanalyse oxygen purity / pureté oxygène >=99.0% analyzer manufacturer: model: serial #: tag #: transportation seal numbers / numéros des sceaux de transport special notes / notes dâinformation: analysis results / rÃsultats dâanalyse 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 air liquide canada oxygen coa