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| Product NDC Code | 11853-013 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Oxygen |
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| Type | Generic | ||||||
| Active Ingredients |
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| Route | RESPIRATORY (INHALATION) | ||||||
| Dosage Form | GAS | ||||||
| RxCUI drug identifier | 312172 | ||||||
| Application Number | NDA205737 | ||||||
| Labeler Name | Air Liquide Large Industries U.S. LP | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Spl product data elements
Usually a list of ingredients in a drug product.OXYGEN OXYGEN OXYGEN OXYGEN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Oxygen USP COA AIR LIQUIDE OXYGEN U.S.P. Form Number: 2A-ALL-QUA-0005-F Revision: 0 Effective Date: 03/29/06 Page: 1/1 CERTIFICATE OF ANALYSIS Air Liquide large Industries U.S. L.P. – Houston, TX 77056 PRODUCED BY AIR LIQUEFACTION 1.Location Street Address1 2. Carrier ________________ Street Address 2 City, State Zip 3. Lot Number ______________________ 4. Trailer No _____________ PRE-FILL REPORT FILL REPORT 5.Residual Assay 6. Odor 7. Trailer loaded with appropriate product per appropriate (>99.5% O 2 ) Detected loading procedure by: _______ % Yes No Signature _________________________ ________ ________ Date _____________________________ Initial Initial ANALYSIS REPORT Test required Method of Analysis Specifications Results OXYGEN ASSAY PARAMAGNETIC ___ 99.5% O 2 Minimum 9. ____% 8.Analyzer Tag Number ODOR Organoleptic (Nasal) None 10. ______ USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide. 11. Analyzed By ________________________ Date ____________ 12. Witnessed By ________________________ Date ____________ (only required for HRC customers) 13. Does this lot require additional testing? ___ NO ___ YES – attach page 2 14. SQCU Review/Release _______________________ Date ____________ MANDATORY FORM User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy. Cert of Analysis
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API