Label: OXYGEN gas

  • NDC Code(s): 11853-013-60, 11853-013-61
  • Packager: Air Liquide Large Industries U.S. LP
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 30, 2019

If you are a consumer or patient please visit this version.

  • Oxygen USP COA

    AIR LIQUIDE  OXYGEN U.S.P.         Form Number: 2A-ALL-QUA-0005-F

                                                                Revision:         0

                                                                Effective Date: 03/29/06

                                                                Page:               1/1

    CERTIFICATE OF ANALYSIS

    Air Liquide large Industries U.S. L.P. – Houston, TX 77056

    PRODUCED BY AIR LIQUEFACTION

    1.Location       Street Address1                                  2. Carrier ________________

    Street Address 2

    City, State Zip

    3. Lot Number ______________________                4. Trailer No _____________

    PRE-FILL REPORT                                                   FILL REPORT

    5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

       (>99.5% O2)                  Detected                                 loading procedure by:

       _______ %                  Yes    No                              Signature _________________________

       ________                    ________                             Date _____________________________

        Initial                            Initial

    ANALYSIS REPORT

    Test required             Method of Analysis                           Specifications                       Results

    OXYGEN ASSAY       PARAMAGNETIC       ___                  99.5% O2 Minimum                9. ____%

                                        8.Analyzer Tag Number        

    ODOR                         Organoleptic (Nasal)                           None                                       10. ______

    USP applies only when used in a medical application or by medical customers properly registered with the FDA. Note: Oxygen that is produced by the air liquefaction process is exempt from the requirement of the impurity test for Carbon Dioxide and Carbon Monoxide.

    11. Analyzed By         ________________________            Date ____________

    12. Witnessed By       ________________________            Date ____________

         (only required for HRC customers)

    13. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

    14. SQCU Review/Release _______________________     Date ____________

    MANDATORY FORM

    User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

    Cert of Analysis

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11853-013
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11853-013-6025000 L in 1 TANK; Type 0: Not a Combination Product01/01/1960
    2NDC:11853-013-6150000 L in 1 TANK; Type 0: Not a Combination Product01/01/1960
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20573701/01/1960
    Labeler - Air Liquide Large Industries U.S. LP (180015062)
    Registrant - Air Liquide Large Industries U.S. LP (180015062)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP791294122manufacture(11853-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP832290014manufacture(11853-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP831993303manufacture(11853-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP047089305manufacture(11853-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP111765132manufacture(11853-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP117158467manufacture(11853-013)