Label: OXYGEN gas

  • NDC Code(s): 11324-001-01, 11324-001-02, 11324-001-03, 11324-001-04, view more
    11324-001-05, 11324-001-06, 11324-001-07, 11324-001-08, 11324-001-09, 11324-001-10, 11324-001-11, 11324-001-12, 11324-001-13
  • Packager: Linde Puerto Rico B.V.
  • 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 26, 2023

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  • PRINCIPAL DISPLAY PANEL

    Oxygen USP GasOxygen USP Liquid

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11324-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11324-001-019543 L in 1 CYLINDER; Type 0: Not a Combination Product10/01/2007
    2NDC:11324-001-027051 L in 1 CYLINDER; Type 0: Not a Combination Product10/01/2007
    3NDC:11324-001-033511 L in 1 CYLINDER; Type 0: Not a Combination Product10/01/2007
    4NDC:11324-001-042350 L in 1 CYLINDER; Type 0: Not a Combination Product10/01/2007
    5NDC:11324-001-05708 L in 1 CYLINDER; Type 0: Not a Combination Product10/01/2007
    6NDC:11324-001-06123140 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    7NDC:11324-001-07123140 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    8NDC:11324-001-08167950 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    9NDC:11324-001-09174791 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    10NDC:11324-001-10137164 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    11NDC:11324-001-11123140 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    12NDC:11324-001-12123140 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    13NDC:11324-001-13153925 L in 1 DEWAR; Type 0: Not a Combination Product10/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas10/01/2007
    Labeler - Linde Puerto Rico B.V. (131438335)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Puerto Rico B.V.131438335manufacture(11324-001)