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| Product NDC Code | 71408-001 | ||||
|---|---|---|---|---|---|
| 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 | NDA211739 | ||||
| Labeler Name | Ineos Pigments ASU LLC | ||||
| Packages |
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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 COA Certificate of Analysis Shipped From: Ashtabula Oxygen 2501 Middle Rd. Ashtabula, Ohio Phone: (440) 994-1994 Company Name: TEST Product: Oxygen Load No: 6 Trailer No: 0000 Time In: 16:56:01 Time Out: 16:56:38 Load Date: 12/26/2017 Tare Weight: 0 Gross Weight: 0 lbs Net Weight: 0 lbs Lot Number: 4004O17360060000 Produced by: Air Liquefaction Ashtabula Oxygen Results Units Specifications Purity Pre-Fill: PASS Pass* Purity Post-Fill: 99.99 % >=99.6% Assay, Tested By: Teledyne 3010MA Paramagnetic The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file. Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications. Signed: Date/Time: Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications. Signed: Date/Time: Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a MSDS. Signed: Date/Time: TF-0001-O Rev.1 Oxygen COA
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