NDC 53440-002 Nitrogen
Gas Respiratory (inhalation)

Product Information

What is NDC 53440-002?

The NDC code 53440-002 is assigned by the FDA to the product Nitrogen which is a human prescription drug product labeled by Westair Gases & Equipment, Inc.. The product's dosage form is gas and is administered via respiratory (inhalation) form. The product is distributed in 9 packages with assigned NDC codes 53440-002-01 240 l in 1 dewar , 53440-002-02 230 l in 1 dewar , 53440-002-03 180 l in 1 dewar , 53440-002-04 160 l in 1 dewar , 53440-002-05 33984 l in 1 cylinder , 53440-002-06 8496 l in 1 cylinder , 53440-002-07 5664 l in 1 cylinder , 53440-002-08 1416 l in 1 cylinder , 53440-002-09 623 l in 1 cylinder . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code53440-002
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Nitrogen
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Nitrogen
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormGas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Westair Gases & Equipment, Inc.
Labeler Code53440
FDA Application Number What is the FDA Application Number?
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.
NDA205766
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-01-2000
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Product Packages

NDC Code 53440-002-01

Package Description: 240 L in 1 DEWAR

NDC Code 53440-002-02

Package Description: 230 L in 1 DEWAR

NDC Code 53440-002-03

Package Description: 180 L in 1 DEWAR

NDC Code 53440-002-04

Package Description: 160 L in 1 DEWAR

NDC Code 53440-002-05

Package Description: 33984 L in 1 CYLINDER

NDC Code 53440-002-06

Package Description: 8496 L in 1 CYLINDER

NDC Code 53440-002-07

Package Description: 5664 L in 1 CYLINDER

NDC Code 53440-002-08

Package Description: 1416 L in 1 CYLINDER

NDC Code 53440-002-09

Package Description: 623 L in 1 CYLINDER

Product Details

What are Nitrogen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • NITROGEN 995 mL/L - An element with the atomic symbol N, atomic number 7, and atomic weight [14.00643; 14.00728]. Nitrogen exists as a diatomic gas and makes up about 78% of the earth's atmosphere by volume. It is a constituent of proteins and nucleic acids and found in all living cells.

Nitrogen Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:

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Nitrogen Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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