Oxygen
Alternacare Home Health Services
Human Prescription Drug
NDC 64097-0001Oxygen is a human prescription drug labeled by 'Alternacare Home Health Services'. National Drug Code (NDC) number for Oxygen is 64097-0001. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Oxygen drug includes Oxygen - 99.5 L/100L . The currest status of Oxygen drug is Active.
Drug Information:
| Drug NDC: | 64097-0001 |
| 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: | Alternacare Home Health Services |
| 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 - 99.5 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: | 01 Jan, 1996 |
| 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: | Alternacare Home Health Services
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312173
|
| 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 |
|---|
| 64097-0001-1 | 142 L in 1 CYLINDER (64097-0001-1) | 01 Jan, 1996 | N/A | No |
| 64097-0001-2 | 235 L in 1 CYLINDER (64097-0001-2) | 01 Jan, 1996 | N/A | No |
| 64097-0001-3 | 393 L in 1 CYLINDER (64097-0001-3) | 01 Jan, 1996 | N/A | No |
| 64097-0001-4 | 646 L in 1 CYLINDER (64097-0001-4) | 01 Jan, 1996 | 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
Warnings:
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. warning: high pressure oxidizing gas vigorously accelerated combustion use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure. open valve slowly. close valve after each use and when empty. keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition. federal law requires that this container be refilled with oxygen usp only by establishments registered as a drug manufacturer in accordance wiith the federal food, drug, and cosmetic act. p
Read more...ursuant to recommendations by compressed gas association, do not expose pressurized cylinders to temperatures in excess of 125 f do not remove this product label use a back flow preventative device in the piping. use only in accordance with product instructions and material safety data sheet.
Warnings and Cautions:
Warning: high pressure gas cylinder improper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. do not alter or modify cylinder or related components. do not over pressurize. keep out of the reach of children. cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. do not use caustic paint strippers. aluminum cylinders subject to action of fire or heated to temperatures in excess of 350 f must be withdrawn from service and condemned. valves and safety relief devices must be removed and replaced by trained personnel. do not alter or change safety discs. replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. do not fill with oxidizing gases without proper cleaning. cylinders, valves and assemblies must be specially cleaned for oxygen. verify cylinder content and pressure monthly, or more frequently if required. store and u
Read more...se with adequate ventilation.
Package Label Principal Display Panel:
Oxygen compressed u.s.p. un 1072 produced by air liquefaction oxygen - 2 cylinder contents at 70 f type b - 142 liters at 1900 psig type c - 235 liters at 1900 psig type d - 393 liters at 1900 psig type e - 646 liters at 1900 psig date code 1104 label 0035-17(1) alternacare_ox