Label: FOCUS MEDICAL OXYGEN- 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 February 24, 2016

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  • Oxygen Compressed USP, UN 1072, RX ONLY

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  • INGREDIENTS AND APPEARANCE
    FOCUS MEDICAL OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70291-1000
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN1 L  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70291-1000-163 L in 1 CYLINDER; Type 0: Not a Combination Product11/24/2015
    2NDC:70291-1000-2170 L in 1 CYLINDER; Type 0: Not a Combination Product11/24/2015
    3NDC:70291-1000-3278 L in 1 CYLINDER; Type 0: Not a Combination Product11/24/2015
    4NDC:70291-1000-41318 L in 1 CYLINDER; Type 0: Not a Combination Product11/24/2015
    5NDC:70291-1000-52642 L in 1 CYLINDER; Type 0: Not a Combination Product11/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas11/01/2015
    Labeler - Focus Medical Gases LLC (084462152)
    Establishment
    NameAddressID/FEIBusiness Operations
    Focus Medical Gases LLC084462152manufacture(70291-1000) , repack(70291-1000)