Carbogen
Westair Gases & Equipment, Inc.
Human Prescription Drug
NDC 53440-008Carbogen is a human prescription drug labeled by 'Westair Gases & Equipment, Inc.'. National Drug Code (NDC) number for Carbogen is 53440-008. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Carbogen drug includes Oxygen - 950 mL/L . The currest status of Carbogen drug is Active.
Drug Information:
| Drug NDC: | 53440-008 |
| 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: | Carbogen |
| 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: | Carbogen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Westair Gases & Equipment, 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 - 950 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: | NDA |
| 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, 2000 |
| 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. |
| Application Number: | NDA205767 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| 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: | Westair Gases & Equipment, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 53440-008-04 | 33984 L in 1 CYLINDER (53440-008-04) | 01 Jan, 2000 | N/A | No |
| 53440-008-05 | 8496 L in 1 CYLINDER (53440-008-05) | 01 Jan, 2000 | N/A | No |
| 53440-008-06 | 5664 L in 1 CYLINDER (53440-008-06) | 01 Jan, 2000 | N/A | No |
| 53440-008-07 | 2832 L in 1 CYLINDER (53440-008-07) | 01 Jan, 2000 | N/A | No |
| 53440-008-08 | 2266 L in 1 CYLINDER (53440-008-08) | 01 Jan, 2000 | N/A | No |
| 53440-008-09 | 1416 L in 1 CYLINDER (53440-008-09) | 01 Jan, 2000 | N/A | No |
| 53440-008-10 | 708 L in 1 CYLINDER (53440-008-10) | 01 Jan, 2000 | N/A | No |
| 53440-008-11 | 425 L in 1 CYLINDER (53440-008-11) | 01 Jan, 2000 | N/A | No |
| 53440-008-12 | 255 L in 1 CYLINDER (53440-008-12) | 01 Jan, 2000 | N/A | No |
| 53440-008-13 | 170 L in 1 CYLINDER (53440-008-13) | 01 Jan, 2000 | N/A | No |
| 53440-008-14 | 113 L in 1 CYLINDER (53440-008-14) | 01 Jan, 2000 | N/A | No |
| 53440-008-15 | 57 L in 1 CYLINDER (53440-008-15) | 01 Jan, 2000 | 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:
Carbogen carbogen carbon dioxide oxygen oxygen
Package Label Principal Display Panel:
Compressed gas, oxidizing, n.o.s. (95% oxygen usp, 5% carbon dioxide usp) un3156 non-flammable gas 2 oxidizer 5.1 rx only. warning: administration of gas mixture may be hazardous or contraindicated. for use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. danger: may cause or intensify fire; oxidizer contains gas under pessure; may explode if heated. may increase respiration and heart rate. 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. 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 degrees c (125 degrees f). read and follow the safety data sheet (sds) before use. first aid: if accidentally inhaled: remove person to fresh air and keep comfortable for breathing. get medical advice/attention. cas: oxygen 7782-44-7, carbon dioxide 124-28-9 do not remove this label. westair 1-866-937-8247 2506 market street, san diego, ca 92102 www.westairgases.com oxygen95 carbondioxide5 mix