Label: OXYGEN gas

  • NDC Code(s): 65464-001-06, 65464-001-09, 65464-001-15, 65464-001-25, view more
    65464-001-60
  • Packager: A PLUS HOME MEDICAL, INC.
  • 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 December 4, 2023

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  • WARNINGS AND PRECAUTIONS

  • PRINCIPAL DISPLAY PANEL

    Oxygen warnings and precautions

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65464-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 99 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65464-001-06165 L in 1 CYLINDER; Type 0: Not a Combination Product09/16/2016
    2NDC:65464-001-09255 L in 1 CYLINDER; Type 0: Not a Combination Product09/16/2016
    3NDC:65464-001-15425 L in 1 CYLINDER; Type 0: Not a Combination Product09/16/2016
    4NDC:65464-001-25680 L in 1 CYLINDER; Type 0: Not a Combination Product09/16/2016
    5NDC:65464-001-601700 L in 1 CYLINDER; Type 0: Not a Combination Product09/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas09/16/2016
    Labeler - A PLUS HOME MEDICAL, INC. (117746903)
    Registrant - A PLUS HOME MEDICAL, INC. (117746903)
    Establishment
    NameAddressID/FEIBusiness Operations
    A PLUS HOME MEDICAL, INC.117746903manufacture(65464-001) , label(65464-001) , transfill(65464-001)