Label: NITROGEN gas

  • NDC Code(s): 46123-044-01
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 19, 2020

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  • PRINCIPAL DISPLAY PANEL

    ROBERTS OXYGEN
    ROCKVILLE, MARYLAND 20866
    TEL: (301) 948-8100

    CERTIFICATE OF ANALYSIS
    NITROGEN REFRIGERATED LIQUID, NF*

    PRODUCED BY AIR-LIQUEFACTION PROCESS

    TRAILER#: ______________

    DATE:  _________________

    LOT#: _________________

    *NF applies only when used in a medical application or by medical customers properly registered with the FDA.

    Component Test Method Limit Result

    NITROGEN DIFF >99.999% _______

    OXYGEN ________ <3.0 PPM _______

    Odor ORGANOLEPTIC N/D ______

    ________ _________ _________ _________

    Product is identified as NITROGEN, NF through process validations, dedicated piping, and product specific connections.

    Notes:  _____________________________________

    RELEASED BY: ____________________________

    SIGNATURE

    RELEASED BY: ____________________________

    PRINTED NAME


    Printed & Published by J.J. KELLER & ASSPCIATES, INC., Neenah, WI * USP

    (800) 327-6868 *jjkeller.com * Printer in the Unitied States



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  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-044
    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:46123-044-011 L in 1 TANK; Type 0: Not a Combination Product07/01/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20585007/01/2002
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-044)