Air
Nexair, Llc
Human Prescription Drug
NDC 12213-700Air is a human prescription drug labeled by 'Nexair, Llc'. National Drug Code (NDC) number for Air is 12213-700. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Air drug includes Air - 1000 mL/L . The currest status of Air drug is Active.
Drug Information:
| Drug NDC: | 12213-700 |
| 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: | Air |
| 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: | Air |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nexair, 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: | AIR - 1000 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 Jun, 1996 |
| 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: | NDA205859 |
| 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: | NexAir, LLC
|
| 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: | K21NZZ5Y0B
|
| 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 |
|---|
| 12213-700-13 | 399 L in 1 CYLINDER (12213-700-13) | 01 Jun, 1996 | N/A | No |
| 12213-700-15 | 1133 L in 1 CYLINDER (12213-700-15) | 01 Jun, 1996 | N/A | No |
| 12213-700-53 | 566 L in 1 CYLINDER (12213-700-53) | 01 Jun, 1996 | N/A | No |
| 12213-700-80 | 13255 L in 1 CYLINDER (12213-700-80) | 01 Jun, 1996 | N/A | No |
| 12213-700-81 | 32282 L in 1 CYLINDER (12213-700-81) | 01 Jun, 1996 | N/A | No |
| 12213-700-82 | 6594 L in 1 CYLINDER (12213-700-82) | 01 Jun, 1996 | N/A | No |
| 12213-700-83 | 8801 L in 1 CYLINDER (12213-700-83) | 01 Jun, 1996 | N/A | No |
| 12213-700-84 | 1698 L in 1 CYLINDER (12213-700-84) | 01 Jun, 1996 | N/A | No |
| 12213-700-85 | 2207 L in 1 CYLINDER (12213-700-85) | 01 Jun, 1996 | N/A | No |
| 12213-700-86 | 662 L in 1 CYLINDER (12213-700-86) | 01 Jun, 1996 | N/A | No |
| 12213-700-87 | 2202 L in 1 CYLINDER (12213-700-87) | 01 Jun, 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:
Air air air air
Package Label Principal Display Panel:
Air, compressed un1002 mixture of oxygen, usp 7782-44-7 nitrogen, nf 7727-37-9 rx only warning: for breathing support when used by properly trained personnel. for medical applications, rx only. administration of medical air 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 medical air 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. warning: contains gas under pressure; may explode if heated. supports combustion. do no handle until all safety precautions have been read and understood. use a back flow preventive device of the piping. use only with equipment of compatible materials of construction and rated for cylinder pressure. 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. net contents contains cu. ft. do not remove this product label. distributed by nexair nexair, llc www.nexair.com 1350 concourse ave., suite 103 memphis, tn 38104 888-639-2474 air
Air, compressed un1002 medical air, usp rx only. warning: for breathing support when used by properly trained personnel. for medical applications, rx only. administration of medical air 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 medical air 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. warning: contains gas under pressure; may explode if heated. supports combustion. do not handle until all safety precautions have been read and understood. use a back flow preventive device in the piping. use only with equipment of compatible materials of construction and rated for cylinder pressure. 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: 132259-10-0 do not remove this product label. distributed by nexair, llc www.nexair.com 1350 concourse ave., suite 103 memphis, tn 38104 lot # part # cf. liters: air two