Label: NITROGEN gas
OXYGEN gas

  • NDC Code(s): 11324-499-01, 11324-721-02, 11324-721-03
  • Packager: Linde Puerto Rico B.V.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 26, 2023

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  • Proof of Delivery Nitrogen NF

    Proof of Delivery N2

  • Proof of Delivery Oxygen USP

    Proof of Delivery O2

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11324-499
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11324-499-0125000 L in 1 TANK; Type 0: Not a Combination Product05/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20585005/22/2013
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11324-721
    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:11324-721-0218000 L in 1 TANK; Type 0: Not a Combination Product05/22/2013
    2NDC:11324-721-0310000 L in 1 TANK; Type 0: Not a Combination Product05/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584905/22/2013
    Labeler - Linde Puerto Rico B.V. (131438335)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Puerto Rico B.V.080049966manufacture(11324-721)
    Establishment
    NameAddressID/FEIBusiness Operations
    Linde Puerto Rico B.V.961672441manufacture(11324-499, 11324-721)
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