Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 23, 2009

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  • Principal for Oxygen Product


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  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57781-1073
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxygen (UNII: S88TT14065) (Oxygen - UNII:S88TT14065) Oxygen99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57781-1073-137 L in 1 DEWAR
    2NDC:57781-1073-236 L in 1 DEWAR
    3NDC:57781-1073-346 L in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas02/05/2003
    Labeler - Promptcare Companies Inc. (557453164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Promptcare Companies Inc.557453164manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Promptcare 557243193manufacture