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Animal NDC 52374-916-20 Nitrogen

Animal Product Information

Field Name Field Value
Animal NDC Code 52374-916-20
Proprietary Name Nitrogen 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.
Non-Proprietary Name Nitrogen 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.
Labeler Name Messer Gas Puerto Rico, Inc
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Nitrogen
Marketing Category NADA - NEW ANIMAL 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.
FDA Application Number NADA141372 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.

Nitrogen Images

Nitrogen Animal 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.

Table of Contents



Warnings And Precautions Section



Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”


Package Label.Principal Display Panel



 

Messer
Gases for Life

Certicate of Analysis - Nitrogen NF

Product: Nitrogen NF

Date

 

Facility Name

 

Facility Address

 

Lot#

 

Batch #

 

Final Analysis Results

Analyzer #

Test/Units

NF Specs

Analysis Results

N/A

Odor

None

 

 

ppm O2

< 10,000

(Messer Spec <5.0)

  ppm

 

ppm CO

< 10.0

  ppm

 

ppm THC

N/A

  ppm

 

ppm H2O

N/A

  ppm

 

ppm CO2

N/A

  ppm

 

ppm H2

N/A

  ppm

Assay Results

Nitrogen min %

> 99.0%

(Messer Spec >99.999%)

%

NT= not tested

ppm O2 method

Used:                  __________________________

Manufacturer/

Model #:                  __________________________

ppm CO method

Used:                  __________________________

Manufacturer/

Model #:                  __________________________

These analyzers have been validated by Messer as acceptable alternatives to the official NF for Nitrogen Assay.  Validation study documentation is maintained by Messer at the corporate offices.

Analyst

Date

 

 

 

 

Quality Reviewer

Date

 

 

 

 

 

Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”

2.5 January 2019

ASU-22-06-GAM-Medical Gas Procedures

Page 1 of 1

Retention Period – 3 Years


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.