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Product NDC Code | 46123-045 | ||||
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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 | NDA205849 | ||||
Labeler Name | Roberts Oxygen Company, Inc. | ||||
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.ROBERTS OXYGEN ROCKVILLE, MARYLAND 20866 TEL: (301) 948-8100 CERTIFICATE OF ANALYSIS OXYGEN REFRIGERATED LIQUID, USP* PRODUCED BY AIR-LIQUEFACTION PROCESS TRAILER#: ______________ DATE: _________________ LOT#: _________________ *USP applies only when used in a medical application or by medical customers properly registered with the FDA. Component Test Method Limit Result Oxygen ______ >99.5% _______ Odor ORGANOLEPTIC N/D ______ ________ _________ _________ _________ Product is identified as OXYGEN, USP through process validations, dedicated piping, and product specific connections. Notes: _____________________________________ RELEASED BY: ____________________________ SIGNATURE RELEASED BY: ____________________________ PRINTED NAME Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP (800) 327-6868 *jjkeller.com * Printer in the Unitied States image label
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