Label: NITROGEN- nitrogen gas

  • NDC Code(s): 11853-023-60, 11853-023-61
  • 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 November 3, 2020

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  • Nitrogen N.F. COA

    AIR LIQUIDE  NITROGEN N.F.        Form Number: 2A-ALL-QUA-0003-F

                                                                Revision:         0

                                                                Effective Date: 03/02/06

                                                                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

       (≤10 ppm O2)                Detected                                 loading procedure by:

       _______ ppm              Yes    No                              Signature _________________________

       ________                    ________                             Date _____________________________

        Initial                            Initial

    ANALYSIS REPORT

    Test required               Method of Analysis                             Specifications                         Results

    ASSAY AND               8.PARAMAGNETIC       ___               99.998% N2 Minimum*           10. ____%

    IDENTIFICATION         MICROFUEL CELL    ___

                                      ELECTROCHEMICAL ___            

                                       CELL                                           10 ppm O2 Maximum             11. _____ppm

                                        9.Analyzer Tag Number        

                                        12.DETECTPR TUBE        ___          10 ppm CO Maximum          14. _____ppm

    CARBON                         INFARED ANALYZER   ___              Expiration Date of Tube       15. ______

    MONOXIDE                                                                         Lot Number of Tube            16. ______

                                        13. Analyzer Tag Number

    ODOR                         Organoleptic (Nasal)                           None                                       17. ______

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

    * Plus inerts

    18. Analyzed By         ________________________            Date ____________

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

    20. 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
    NITROGEN  
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11853-023
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11853-023-6025000 L in 1 TANK; Type 0: Not a Combination Product01/01/1960
    2NDC:11853-023-6150000 L in 1 TANK; Type 0: Not a Combination Product01/01/1960
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20573801/01/1960
    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(11853-023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP832290014manufacture(11853-023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP831993303manufacture(11853-023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP047089305manufacture(11853-023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP111765132manufacture(11853-023)
    Establishment
    NameAddressID/FEIBusiness Operations
    Air Liquide Large Industries U.S. LP117158467manufacture(11853-023)