Oxygen
Aerocare Holdings, Llc
Human Prescription Drug
NDC 65551-001Oxygen is a human prescription drug labeled by 'Aerocare Holdings, Llc'. National Drug Code (NDC) number for Oxygen is 65551-001. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Oxygen drug includes Oxygen - 99 L/100L . The currest status of Oxygen drug is Active.
Drug Information:
| Drug NDC: | 65551-001 |
| 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: | Aerocare Holdings, Llc |
| 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 - 99 L/100L
|
| 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: | 12 Mar, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Dec, 2025 |
| 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: | AeroCare Holdings, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312172
|
| 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 |
|---|
| 65551-001-01 | 10 L in 1 DEWAR (65551-001-01) | 12 Mar, 2015 | N/A | No |
| 65551-001-02 | 21 L in 1 DEWAR (65551-001-02) | 12 Mar, 2015 | N/A | No |
| 65551-001-03 | 31 L in 1 DEWAR (65551-001-03) | 12 Mar, 2015 | N/A | No |
| 65551-001-04 | 41 L in 1 DEWAR (65551-001-04) | 12 Mar, 2015 | N/A | No |
| 65551-001-05 | 46 L in 1 DEWAR (65551-001-05) | 12 Mar, 2015 | N/A | No |
| 65551-001-06 | 76 L in 1 DEWAR (65551-001-06) | 12 Mar, 2015 | N/A | No |
| 65551-001-07 | 119 L in 1 DEWAR (65551-001-07) | 12 Mar, 2015 | N/A | No |
| 65551-001-08 | 190 L in 1 DEWAR (65551-001-08) | 12 Mar, 2015 | N/A | No |
| 65551-001-09 | 165 L in 1 CYLINDER (65551-001-09) | 12 Mar, 2015 | N/A | No |
| 65551-001-10 | 255 L in 1 CYLINDER (65551-001-10) | 12 Mar, 2015 | N/A | No |
| 65551-001-11 | 425 L in 1 CYLINDER (65551-001-11) | 12 Mar, 2015 | N/A | No |
| 65551-001-12 | 680 L in 1 CYLINDER (65551-001-12) | 12 Mar, 2015 | N/A | No |
| 65551-001-13 | 1738 L in 1 CYLINDER (65551-001-13) | 12 Mar, 2015 | N/A | No |
| 65551-001-14 | 3455 L in 1 CYLINDER (65551-001-14) | 12 Mar, 2015 | N/A | No |
| 65551-001-15 | 7080 L in 1 CYLINDER (65551-001-15) | 12 Mar, 2015 | 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:
Principal for oxygen product oxygen, refrigerated liquid usp un 1073 contents ________________liters cas no: 7782-44-7 danger: may cause or intensify fire; oxidizer. contains refrigerated gas; may cause cryogenic burns or injury. combustibles in contact with liquid oxygen may explode on ignition or impact. 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. wear cold insulating gloves, face shield, and eye protection. 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. do not change or force fit connections. avoid spills. do not walk on or roll equipment over spills. close valve after each use and when empty. always keep container in upright position. read and follow the safety data sheet (sds) before use. first aid: if on skin: thaw frosted parts with lukewarm water. do not rub affected area. get immediate medical advice/attention. do not remove this product label. warning: for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. for all other medical applications, rx only. uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. produced by air liquefaction. oxygen compressed usp un 1072 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 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 52 °c (125 °f). read and follow the safety data sheet (sds) before use. cas no: 7782-44-7 do not remove this product label. warning: for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. for all other medical applications, rx only. uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. produced by air liquefaction. representativeloxlabel representativehplabel representativelotsticker