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Animal NDC 45149-914-01 Carbon Dioxide

Animal Product Information

Field Name Field Value
Animal NDC Code 45149-914-01
Proprietary Name Carbon Dioxide 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 Carbon Dioxide 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 Merchant Production Llc
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Carbon Dioxide
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 NADA141371 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.

Carbon Dioxide Images

Carbon Dioxide 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



BULK CARBON DIOXIDE USP CERTIFICATE OF ANALYSIS

This is to certify that the carbon dioxide produced at ______________________ on ______________________ meets the United States Pharmacopeia (USP) specifications, the requirements of Federal Specifications BB-C-101 Grade A and QVL E of CGA G6.2. This product was manufactured at a facility registered with the Federal Food and Drug Administration and is approved for prescription drug use. This product is not guaranteed to meet any other specification or intended for pesticide use.


Furthermore, batch number ______________________ and lot number ______________________, which was loaded on ______________________and filled at ______________________, comprises this shipment and was analyzed as shown below.


Analytical results are generated using USP monograph or validated equivalent methods.

RequirementTest MethodLimit of DetectionSpecification LimitAnalysis Results
Carbon Dioxide Assay (CO2)Zahm Nagel99.00%≥ 99.0%
Nitrogen Oxides (NOx)Detector Tube0.5 ppm2.5 ppm each
Ammonia (NH3)Detector Tube0.25 ppm25 ppm
Total SulfurAnalyzer10 ppb1000 ppb
Carbon Monoxide (CO)Detector Tube0.5 ppm10 ppm
Moisture (H2O)Analyzer0.5 ppm200 ppm or -33°F Dew Point

Note:
1) Positive Carbon Dioxide Identification is achieved when the Assay results demonstrate meeting the specification.
2) The limit of detection (LOD) for each test method is the threshold value for results to be reported with certainty in the accuracy of results. A test result outside the detection limit for the test method will be reported as ND.
3) ND=None Detected
4)ppm= parts per million by volume, ppb=parts per billion by volume, 1ppm=1,000 ppb
5) H2S, SO2, and other sulfur species are included in the total sulfur amount

Product analyzed using Messer Premier Guard Analysis suite


Analyst____________________________________________  Date: __________________________________



Reviewed and released by:____________________________  Date: __________________________________



_______________________________________________________________________

March 2019
CO2-22-06-RNA-Medical Gas USP Procedures
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Retention Period - 3 years


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