NDC 81676-001 Oxygen

Oxygen

NDC Product Code 81676-001

NDC 81676-001-01

Package Description: 170 L in 1 CYLINDER

NDC 81676-001-02

Package Description: 248 L in 1 CYLINDER

NDC 81676-001-03

Package Description: 415 L in 1 CYLINDER

NDC 81676-001-04

Package Description: 682 L in 1 CYLINDER

NDC 81676-001-05

Package Description: 6910 L in 1 CYLINDER

NDC Product Information

Oxygen with NDC 81676-001 is a a human prescription drug product labeled by Joerns Llc. The generic name of Oxygen is oxygen. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Labeler Name: Joerns Llc

Dosage Form: Gas - Any elastic aeriform fluid in which the molecules are separated from one another and so have free paths.

Product Type: Human Prescription Drug 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.

Oxygen Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYGEN 99 L/100L

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.

Labeler Name: Joerns Llc
Labeler Code: 81676
FDA Application Number: NDA206023 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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. 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.

Start Marketing Date: 03-08-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

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Oxygen Product Label Images

Oxygen Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Oxygen

OXYGEN, COMPRESSED USP UN 1072 OXYGEN 2(R-K14) XXXXXXC.A.S. 7782-44-7Joerns®19211 Chennault Way Suite C • Gaithersburg, MD 20879800-528-1001DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. 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. DO NOT REMOVE THIS PRODUCT LABEL.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.SIZE CONTENTS                                 SIZE CONTENTS__ M6   170 Liters                            __ E        682 Liters__ C       248 Liters                            __ H       6910 Liters__ D       415 Liters                            __ Other   ____ Liters

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