Label: OXYGEN gas

  • NDC Code(s): 46123-045-01
  • Packager: Roberts Oxygen Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 16, 2023

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  • PRINCIPAL DISPLAY PANEL

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

    CERTIFICATE OF ANALYSIS
    OXYGEN REFRIGERATED LIQUID, USP*

    PRODUCED BY AIR-LIQUEFACTION PROCESS

    TRAILER#: ______________

    DATE:  _________________

    LOT#: _________________

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

    Component Test Method Limit Result

    Oxygen ______ >99.5% _______

    Odor ORGANOLEPTIC N/D ______

    ________ _________ _________ _________

    Product is identified as OXYGEN, USP 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

    image label

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:46123-045
    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:46123-045-011 L in 1 TANK; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20584901/01/2014
    Labeler - Roberts Oxygen Company, Inc. (042646877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Roberts Oxygen Company, Inc.791818008manufacture(46123-045)
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