NDC 65603-100 Oxygen
Gas Respiratory (inhalation)

Product Information

What is NDC 65603-100?

The NDC code 65603-100 is assigned by the FDA to the UNFINISHED product Oxygen which is a human prescription drug product labeled by Arkansas Welding Supply, Inc.. The product's dosage form is gas and is administered via respiratory (inhalation) form. The product is distributed in 15 packages with assigned NDC codes 65603-100-01 105 l in 1 cylinder , 65603-100-02 150 l in 1 cylinder , 65603-100-03 209 l in 1 cylinder , 65603-100-04 248 l in 1 cylinder , 65603-100-05 420 l in 1 cylinder , 65603-100-06 690 l in 1 cylinder , 65603-100-07 1724 l in 1 cylinder , 65603-100-08 3470 l in 1 cylinder , 65603-100-12 160 l in 1 dewar , 65603-100-13 41 l in 1 dewar , 65603-100-14 6270 l in 1 cylinder , 65603-100-15 8510 l in 1 cylinder , 65603-100-16 3160 l in 1 cylinder , 65603-100-17 3270 l in 1 cylinder , 65603-100-18 180 l in 1 dewar . 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 Code65603-100
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.		Oxygen
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.		Oxygen
Substance Name What is the Substance Name?
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.		Oxygen
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.		Arkansas Welding Supply, Inc.
Labeler Code65603
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.		NDA205840
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.		10-20-2001
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
Unfinished Product What is an Unfinished Product?
Not Available		Yes
NDC Code Structure

Product Packages

NDC Code 65603-100-01

Package Description: 105 L in 1 CYLINDER

NDC Code 65603-100-02

Package Description: 150 L in 1 CYLINDER

NDC Code 65603-100-03

Package Description: 209 L in 1 CYLINDER

NDC Code 65603-100-04

Package Description: 248 L in 1 CYLINDER

NDC Code 65603-100-05

Package Description: 420 L in 1 CYLINDER

NDC Code 65603-100-06

Package Description: 690 L in 1 CYLINDER

NDC Code 65603-100-07

Package Description: 1724 L in 1 CYLINDER

NDC Code 65603-100-08

Package Description: 3470 L in 1 CYLINDER

NDC Code 65603-100-12

Package Description: 160 L in 1 DEWAR

NDC Code 65603-100-13

Package Description: 41 L in 1 DEWAR

NDC Code 65603-100-14

Package Description: 6270 L in 1 CYLINDER

NDC Code 65603-100-15

Package Description: 8510 L in 1 CYLINDER

NDC Code 65603-100-16

Package Description: 3160 L in 1 CYLINDER

NDC Code 65603-100-17

Package Description: 3270 L in 1 CYLINDER

NDC Code 65603-100-18

Package Description: 180 L in 1 DEWAR

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Product Details

What are Oxygen 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.
  • OXYGEN 992 mL/L - An element with atomic symbol O, atomic number 8, and atomic weight [15.99903; 15.99977]. It is the most abundant element on earth and essential for respiration.

Oxygen 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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Oxygen 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



Package Label.Principal Display Panel



OXYGEN, COMPRESSED USP UN1072
AWI SUPPLY 230 Valley Street Hot Springs, AR 71901 501-321-9922
OXYGEN 2
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Produced by Air Liquefaction. DANGER: MAY CAUSE OR INTENCIFY FIRE; OXYDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire; Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for oxygen service. Open valve slowly. 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: 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL

oxygen one - oxygen1

oxygen one - oxygen1

oxygen one - oxygen1

oxygen one - oxygen1

AWI SUPPLY OXYGEN PRODUCED BY AIR-LIQUEFACTION PROCESS MEETS USP REQUIREMENTS

FACILITY___ UNIT NO.___ TESTER NO.___ QUANTITY___CU.FT.

LOT NO.___ PURITY___ IDENTITY___ ___ODOR WITNESS___

DATE___ OPERATOR___

ARKANSES WELDING AND INDUSTRIAL SUPPLY, INC. CERTIFIES THE OXYGEN PRODUCT DELIVERED MEETS AND EXCEEEDS PURITY SPECIFICATIONS FOR USP PRODUCT AS DEFINED BY THE FOOD AND DRUG ADMINISTRATION.

THIS TAG MUST BE REMOVED ONLY BY EMPLOYEE RESPONSIBLE FOR REFILLING


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