Oxygen
Ucg Georgia, Llc
Human Prescription Drug
NDC 72457-003Oxygen is a human prescription drug labeled by 'Ucg Georgia, Llc'. National Drug Code (NDC) number for Oxygen is 72457-003. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Oxygen drug includes Oxygen - 990 mL/L . The currest status of Oxygen drug is Active.
Drug Information:
| Drug NDC: | 72457-003 |
| 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: | Ucg Georgia, 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: | OXYGEN - 990 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 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 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: | NDA212314 |
| 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: | UCG Georgia, LLC
|
| 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 |
|---|
| 72457-003-01 | 1.9547 L in 1 TANK (72457-003-01) | 01 Nov, 2018 | N/A | No |
| 72457-003-02 | 22712.47 L in 1 TANK (72457-003-02) | 01 Nov, 2018 | 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
Package Label Principal Display Panel:
Uig universal industrial gases, inc certificate of analysis all usp oxygen delivered by universal industrial gases, inc, when used in a medical application or by medical customers properly registered with the fda, is classified as usp shipped from taylor data systems 181 e. evans st suite a florence, sc 29505 843-656-2084 company: taylor data systems operator: admin product: oxygen product code: ox 200 driver: benton little tractor no: 14 trailer no: 12 load no: 111 certificate no: 242 tank no: 1000 time in: 10:47 am time out: 10:49 am certification date: 6/22/2018 10:49 am tare weight: 10000 lbs gross weight: 10000 lbs net weight: 0 lbs lot number: tds-161-18-o-1000-2 produced by: tyler results units usp/nf specifications tds specifications purity pre-fill 97.00 % >=97.00 % >=97.00 % purity post-fill 99.00 $ >=99.00 % >=99.50 % paramagnetic odor none none none organoleptic identity oxygen oxygen oxygen dew point -85.50 deg. f 0.00 deg. f moisture 5.00 ppm/v <=5.00 ppm/v - critical analyzers yes yes *the pre-fill is tested against uigi specifications and a pass indicates that the results met or exceeded the applicable specifications. the results of the pre-fill tests are kept on file. quantity delivered to trailer: 0.00 gallons: 1.26 cubic feet: 0.00 uigi analyst: i declare that this analysis was completed within all uigi policy and procedures and that the product meets all uigi specifications. signed: date: 06/22/2018 product release specialist / released by: i declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all uigi specifications. signed: date: 06/22/2018 picked up by: i declare that i have received the required documentation for shipment of this product and that i have the north american emergency response guide or a sds. signed: date: 06/22/2018 oxygen