Oxygen
Bernens Convalescent Pharmacy, Inc
Human Prescription Drug
NDC 57957-0007Oxygen is a human prescription drug labeled by 'Bernens Convalescent Pharmacy, Inc'. National Drug Code (NDC) number for Oxygen is 57957-0007. 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: | 57957-0007 |
| 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: | Bernens Convalescent Pharmacy, 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 - 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: | 01 Jan, 1976 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | Bernens Convalescent Pharmacy, Inc
|
| 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 |
|---|
| 57957-0007-1 | 25 L in 1 CYLINDER (57957-0007-1) | 01 Jan, 1976 | N/A | No |
| 57957-0007-2 | 37 L in 1 CYLINDER (57957-0007-2) | 01 Jan, 1976 | N/A | No |
| 57957-0007-3 | 400 L in 1 CYLINDER (57957-0007-3) | 01 Jan, 1976 | N/A | No |
| 57957-0007-4 | 630 L in 1 CYLINDER (57957-0007-4) | 01 Jan, 1976 | N/A | No |
| 57957-0007-5 | 6900 L in 1 CYLINDER (57957-0007-5) | 01 Jan, 1976 | N/A | No |
| 57957-0007-6 | 22800 L in 1 CYLINDER (57957-0007-6) | 01 Jan, 1976 | N/A | No |
| 57957-0007-7 | 28800 L in 1 CYLINDER (57957-0007-7) | 01 Jan, 1976 | 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 and Cautions:
Product warnings and precautions first aid: for oxygen deficiency in breathing persons or emergency resuscitation when used by personnel instructed in oxygen administration. for other medical applications use only as directed by a licensed practitioner. uninterrupted use of high concentrations of oxygen over a long duration without monitoring its effect on oxygen content of arterial blood may be harmful. use only with pressure reducing equipment and apparatus designed for oxygen. do not remove this product label. caution: federal law prohibits dispensing without a prescription. in case of frostbite obtain professional medical treatment immediately.
Package Label Principal Display Panel:
Oxygen refrigerated label oxygen u.s.p. refrigerated liquid - oxygen un 1073 produced by air liquefaction marketed by bernens medical warning: always keep container in upright position. extremely cold oxidizing liquid and gas under pressure. vigorously accelerates combustion. combustibles in contact with liquid oxygen may explode on ignition or impact. can cause severe frostbite. keep oil, grease and combustibles away. use only with equipment cleaned for oxygen service. store and use with adequate ventilation. do not get liquid in eyes, on skin, or clothing. for liquid withdrawal wear face shield and gloves. do not drop or handle container roughly. use hand truck for container movement. avoid spills. do not walk on or roll equipment over spills. close valve after each use and when empty. use in accordance with compressed gas association pamphlets g-4, g-4.1, g-4.4, p-1, p-12, and p-14 and with material safety data sheet. 253 liquid label