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Animal NDC 52374-911-20 Oxygen

Animal Product Information

Field Name Field Value
Animal NDC Code 52374-911-20
Proprietary Name Oxygen 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 Oxygen 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)
  • Oxygen
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 NADA141374 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.

Oxygen Images

Oxygen 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



Package Label.Principal Display Panel



Certificate of Analysis – Oxygen USP

Product:
Oxygen USP

Date

Facility Name

Facility Address

Lot #

Batch #

Final Analysis Results

Analyzer #

Test / Units

USP Specs

Analysis Results

N/A

Odor

None

% O₂

≥99.0%

%

(Messer Spec ≥99.50%)

ppm H₂O

N/A

ppm

ppm THC

N/A

ppm

N/A

% CO

≤ .001

***

N/A

% CO₂

≤ .03

***

NT = not tested
*** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.

The methodology used to perform the USP test:

Paramagnetic Analyzer Manufacturer/Model #:

This analyzer has been validated by Messer as acceptable alternatives to the official USP for Oxygen 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 USP customer, the material is “Not Approved for Human Drug Use.”

Certificate of Analysis – Oxygen USP

Product:
Oxygen USP

Date

Facility Name

Facility Address

Lot #

NDA

205818

Batch #

NADA 141374

Final Analysis Results

Analyzer #

Test / Units

USP Specs

Analysis Results

N/A

Odor

None

% O₂

≥99.0%

%

(Messer Spec ≥99.50%)

ppm H₂O

N/A

ppm

ppm THC

N/A

ppm

N/A

% CO

≤ .001

***

N/A

% CO₂

≤ .03

***

NT = not tested
*** = This product was manufactured by Air Liquefaction and testing is exempt under the USP compendium.

The methodology used to perform the USP test:

Paramagnetic Analyzer Manufacturer/Model #:

This analyzer has been validated by Messer as acceptable alternatives to the official USP for Oxygen 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 USP customer, the material is “Not Approved for Human Drug Use.”


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