NDC 64922-240 Nitrogen

Nitrogen

NDC Product Code 64922-240

NDC 64922-240-01

Package Description: 7400 L in 1 CYLINDER

NDC 64922-240-02

Package Description: 160 L in 1 DEWAR

NDC 64922-240-03

Package Description: 180 L in 1 DEWAR

NDC 64922-240-04

Package Description: 20 L in 1 DEWAR

NDC 64922-240-05

Package Description: 30 L in 1 DEWAR

NDC Product Information

Nitrogen with NDC 64922-240 is a a human prescription drug product labeled by Adf Welding & Medical, Inc.. The generic name of Nitrogen is nitrogen. The product's dosage form is gas and is administered via respiratory (inhalation) form.

Labeler Name: Adf Welding & Medical, Inc.

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.

Nitrogen 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.

  • NITROGEN 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: Adf Welding & Medical, Inc.
Labeler Code: 64922
FDA Application Number: NDA205766 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: 01-01-1990 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: 12-31-2021 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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Nitrogen 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

Nitrogen Refrigerated Liquid Label

NITROGEN REFRIGERATED LIQUID NF UN 1977 NON-FLAMMABLE GAS  CONTENTS ________________ LOT NUMBER ________________  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION  DO NOT REMOVE THIS PRODUCT LABEL  WARNING Rx ONLY.  PLEASE REFER TO THE MATERIAL SAFETY DATA SHEET FOR SAFETY AND PRODUCT INFORMATIONIF INHALED, REMOVE TO FRESH AIR.  IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION.  IF BREATHING IS DIFFICULT, GIVE OXYGEN.  CALL A PHYSICIAN.  IN CASE OF FROSTBITE, OBTAIN MEDICAL TREATMENT IMMEDIATELY.PART # DB-NNF PRINTED BY RATERMANN MFG INC.  925-606-2949

Nitrogen Compressed Label

NITROGEN COMPRESSED NF UN 1066 NON-FLAMMABLE GAS - 2 DO NOT REMOVE THIS PRODUCT LABELCONTENTS ________ PRESSURE ____________ CAUTION: HIGH PRESSURE GAS CAN CAUSE RAPID SUFFOCATION.  STORE AND USE WITH ADEQUATE VENTILATION.  USER SHALL SECURE CYLINDER IN USE AND IN STORAGE.  USE IN UPRIGHT POSITION.  USE ONLY WITH EQUIPMENT DESIGNATED FOR NITROGEN SERVICE AND RATED FOR CYLINDER PRESSURE.  CLOSE VALVE AFTER EACH USE.  KEEP VALVE PROTECTIVE CAP IN PLACE WHEN NOT IN USE IF SO EQUIPPED.  USE IN ACCORDANCE WITH MSDS.  CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.  WARNING: ADMINISTRATION OF NITROGEN MAY BE HAZARDOUS OR CONTRAINDICATED.  FOR USE ONLY BY OR UNDER THE SUPERVISION OF A LICENSED PRACTITIONER WHO IS EXPERIENCED IN THE USE AND ADMINISTRATION OF NITROGEN AND IS FAMILIAR WITH THE INDICATIONS, EFFECTS, DOSAGES, METHODS, AND FREQUENCY AND DURATION OF ADMINISTRATION, AND WITH THE HAZARDS, CONTRAINDICATIONS AND SIDE EFFECTS AND THE PRECAUTIONS TO BE TAKEN.  FIRST AID: IF INHALED REMOVE TO FRESH AIR.  IF NOT BREATHING, GIVE ARTIFICIAL RESPIRATION.  IF BREATHING IS DIFFICULT GIVE OXYGEN, CALL A PHYSICIAN.  CAS 7727-37-9 RETURN WITH 25 PSIG.  LABEL 14

Nitrogen Certificate Of Analysis

CUSTOMER ___________________  VENDOR / SUPPLIER ________________________  THIS LETTER IS TO PROVIDE YOU WITH THE                CERTIFICATION YOU REQUESTED FOR NITROGEN NF LOT NUMBER _______________________ SUPPLIED TO YOU IN               CYLINDERS / VESSELS BY OUR LOCATION               These cylinders were filled in accordance with the Standard Operating Procedures utilized for the manufacture of Medical Gases.  By                following these procedures, our location ensures that products are safely manufactured in compliance with FDA’s Current Good Manufacturing Practices                (cGMP) Regulations.                 CAUTION: VENDOR SUPPLIES THIS CERTIFICATION TO CUSTOMER TO ASSIST CUSTOMER IN ENSURING COMPLIANCE WITH 21 CFR 211.84.  THIS                CERTIFICATION DOES NOT ELIMINATE CUSTOMERS OBLIGATION TO COMPLY WITH OTHER PORTIONS OF 21 CFR 210 AND 211, INCLUDING BUT NOT               LIMITED TO 21 CFR 211.165 (FINISHED PRODUCT TESTING) FOR CYLINDERS AND VESSELS FILLED FROM THESE SUPPLY CYLINDERS.  THESE CYLINDERS ARE               NOT CERTIFIED FOR INSTRUMENT CALIBRATION. TEST REQUIREMENT           USP SPECIFICATION                  LOT ANALYSISIDENTIFICATION                         PASS ODOR                                        PASS CARBON DIOXIDE                    LESS THAN 1.0% CARBON MONOXIDE                LESS THAT 10 PPM ASSAY                                     GREATER THAN 99.0% The methodology being used to perform the NF Test for                Assay is indicated below:   Paramagnetic Analyzer    Model # ________________________ ELECTROCHEMICAL ANALYZER MODEL #________________ GAS CHROMATOGRAPHY OFFICIAL USP / NF METHOD

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