Carbon Dioxide Oxygen Mixture
Spec Connection International Inc
Human Prescription Drug
NDC 54776-004Carbon Dioxide Oxygen Mixture is a human prescription drug labeled by 'Spec Connection International Inc'. National Drug Code (NDC) number for Carbon Dioxide Oxygen Mixture is 54776-004. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Carbon Dioxide Oxygen Mixture drug includes Oxygen - 800 mL/L . The currest status of Carbon Dioxide Oxygen Mixture drug is Active.
Drug Information:
| Drug NDC: | 54776-004 |
| 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: | Carbon Dioxide Oxygen Mixture |
| 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: | Carbon Dioxide Oxygen Mixture |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Spec Connection International 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 - 800 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, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | NDA205889 |
| 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: | Spec Connection International Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 899763
|
| 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 |
|---|
| 54776-004-01 | 707 L in 1 CYLINDER (54776-004-01) | 01 Jan, 2013 | N/A | No |
| 54776-004-02 | 5663 L in 1 CYLINDER (54776-004-02) | 01 Jan, 2013 | 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:
Carbon dioxide oxygen mixture carbon dioxide oxygen mixture oxygen oxygen carbon dioxide
Package Label Principal Display Panel:
Oxygen 2 non-flammable 2 carbon dioxide and oxygen mixtures, compressed (carbon dioxide, oxygen) un1014 medical gas mixture 5% carbon dioxide, usp cas: 124-38-9 balance oxygen, usp cas: 7782-44-7 caution: federal law prohibits dispensing without a prescription. rx only. warning: oxidizing high pressure gas. vigorously accelerates combustion. can increase respiration and heart rate. keep oil and grease away. cylinder temperature should not exceed 125f (52c). use only with equipment cleaned for oxygen service and rated for cylinder pressure. use equipment rated for cylinder pressure. store and use with adequate ventilation. do not get in eyes, on skin or clothing. close valve after each use and when empty. open valve slowly, administration of this 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. secure cylinder while in transportation, storage and in use. spec connection internaltional, inc. 37325 state road 54. zephyrhills, fl 33542 813-997-7646 do not remove this product label. co2 o2