Label: NITROGEN gas

  • NDC Code(s): 71408-003-01
  • Packager: Ineos Pigments Asu LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 18, 2019

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  • Nitrogen

    Certificate of Analysis                    Shipped From:

                                                                                                                    Ashtabula Oxygen

                                                                                                                    2501 Middle Rd.

                                                                                                                    Ashtabula, Ohio                              

                                                                                                                    Phone: (440) 994-1994

    Company Name: TEST

    Product:               Nitrogen

    Load No:              5                                                                                              Trailer No:          0000

    Time In:               16:44:58               Time Out:            16:46:04               Load Date:          12/26/2017

    Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs

    Lot Number:      4004N17360050000                                         Produced by: Air Liquefaction

      Assay per NF requirements is by difference of O2 only

    Ashtabula Oxygen

    ResultsUnitsSpecifications

    Purity Pre-Fill:                  PASS                                                                      Pass*

    Purity Post-Fill:                99.99                     %                            >=99.999%

    Assay, By Difference)

    O2:                                                                         ppm/V                  <=2.0ppm

      O2 Tested By: Teledyne 3000TA-XL Electrochemcial

    CO:                                                                         ppm/V                  <=5.0ppm

      CO Tested By: Teledyne GFC-7001T Non-Dispersive Infrared

    H2O:                                                                      ppm/V                  <=2.0ppm

      H20 Tested By: Teledyne 8800A Electrochemcial

    Odor:                                                                    None                     None

      Odor Tested By: Organoleptic

    • The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

    Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

    Signed:         Date/Time:

    Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

    Signed:         Date/Time:

    Picked Up By: I declare that I have received the required documentation for shipment of this product and that I have the North American Emergency Response Guide or a MSDS.

    Signed:         Date/Time:

    Nitrogen COA

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71408-003
    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:71408-003-0110000 L in 1 TANK; Type 0: Not a Combination Product12/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21173712/27/2017
    Labeler - Ineos Pigments Asu LLC (080634966)
    Registrant - Ineos Pigments Asu LLC (080634966)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ineos Pigments Asu LLC080634966manufacture(71408-003)