Nitrogen
Air Liquide Large Industries U.s. Lp
Human Prescription Drug
NDC 11853-023Nitrogen is a human prescription drug labeled by 'Air Liquide Large Industries U.s. Lp'. National Drug Code (NDC) number for Nitrogen is 11853-023. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Nitrogen drug includes Nitrogen - 99 L/100L . The currest status of Nitrogen drug is Active.
Drug Information:
| Drug NDC: | 11853-023 |
| 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: | Nitrogen |
| 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: | Nitrogen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Air Liquide Large Industries U.s. Lp |
| 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: | NITROGEN - 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: | 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, 1960 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | NDA205738 |
| 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: | Air Liquide Large Industries U.S. LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 311998
|
| 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: | N762921K75
|
| 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 |
|---|
| 11853-023-60 | 25000 L in 1 TANK (11853-023-60) | 01 Jan, 1960 | N/A | No |
| 11853-023-61 | 50000 L in 1 TANK (11853-023-61) | 01 Jan, 1960 | 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:
Nitrogen nitrogen nitrogen nitrogen
Package Label Principal Display Panel:
Nitrogen n.f. coa air liquide nitrogen n.f. form number: 2a-all-qua-0003-f revision: 0 effective date: 03/02/06 page: 1/1 certificate of analysis air liquide large industries u.s. l.p. â houston, tx 77056 produced by air liquefaction 1.location street address1 2. carrier ________________ street address 2 city, state zip 3. lot number ______________________ 4. trailer no _____________ pre-fill report fill report 5.residual assay 6. odor 7. trailer loaded with appropriate product per appropriate (â¤10 ppm o 2 ) detected loading procedure by: _______ ppm yes no signature _________________________ ________ ________ date _____________________________ initial initial analysis report test required method of analysis specifications results assay and 8.paramagnetic ___ 99.998% n 2 minimum* 10. ____% identification microfuel cell ___ electrochemical ___ cell 10 ppm o 2 maximum 11. _____ppm 9.analyzer tag number 12.detectpr tube ___ 10 ppm co maximum 14. _____ppm carbon infared analyzer ___ expiration date of tube 15. ______ monoxide lot number of tube 16. ______ 13. analyzer tag number odor organoleptic (nasal) none 17. ______ n.f. applies only when used in a medical application or by medical customers properly registered with the fda. * plus inerts 18. analyzed by ________________________ date ____________ 19. does this lot require additional testing? ___ no ___ yes â attach page 2 20. sqcu review/release _______________________ date ____________ mandatory form user must assure that this revision of the form is current prior to use. completed forms become permanent records subject to the record retention policy. cert of analysis