Label: NITROGEN gas

  • NDC Code(s): 46123-004-01, 46123-004-02, 46123-004-03
  • Packager: Roberts Oxygen Company, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 1, 2021

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  • PRINCIPAL DISPLAY PANEL

    NITROGEN,
    REFRIGERATED LIQUID
    NF
    UN1977
    Roberts Oxygen Company, Inc.
    P.O. Box 5507 Rockville, MD 20855
    301-948-8100
    NON-FLAMMABLE GAS 2
    ↑ALWAYS KEEP CONTAINER IN UPRIGHT POSITION↑
    WARNING:
    Rx only. Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of nitrogen and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken.
    WARNING: CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION.
    Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. Use a back flow preventative device in the piping. DO NOT change or force fit connections. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.
    FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
    IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention.
    DO NOT REMOVE THIS PRODUCT LABEL.
    CAS: 7727-37-9

    image of cylinder label
  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-004
    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:46123-004-01120380 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1967
    2NDC:46123-004-02123396 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1967
    3NDC:46123-004-03167184 L in 1 DEWAR; Type 0: Not a Combination Product01/01/1967
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20585001/01/1967
    Labeler - Roberts Oxygen Company, Inc (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.020325953manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.037669104manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.080569994manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.116950907manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.117356466manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.783854045manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.926687468manufacture(46123-004)