Label: NITROUS OXIDE- nitrous oxide gas

  • NDC Code(s): 72223-001-01
  • Packager: Praxair Mexico, S. de R.L. de C.V
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 8, 2018

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

  • NITROUS OXIDE USP LABEL

    PRAXAIR              Praxair Mexico S. de, R.L. de C.V.

                                    Laboraicarlo de Costrel de Calidad de Producto

                                    Plasia Toluca

                                    Av Independence Ote No 300

                                    CP 50070 Toluca Ede de Mexico

                                    Tel          (722)2358800

    Certificate of Analysis (COA)

    Customer Name:              Praxair Distribution Inc.

    Date:     March 23 th, 2018                            COA US 0928

    Shipping Container:  63273

    Product:                                               Nitrous Oxide USP Medical Gas

    Pharmaceutical form:                    Medicinal gas    

    Purity:                                                  99.0 cmol/ mol Min.       Expiration Date:               March 23 th, 2020

    DUNS:                                                   8129539029                         FDA Establishment Identifier: 3012518051

    Batch Number:                 TCM-N20-MED-002-18

    This product described in this document meets the requirements of the United States Pharmacopeia 39th edition 2016, Mexican United States Pharmacopeia, 11th edition 2014, Praxair Mexico, S. de R.L. de C.V. and Praxair Distribution, Inc.

    Component                        Specification                     Test Procedure                 Results

    Nitrous Oxide Purity        Min. 99.0 cmol/moi         Gas Chromatograph        99.84 cmol/mol

    Carbon Monoxide            Max. 5.0 µmol/mol          Detector tube                    < 5 µmol/mol

    Carbon Dioxide                 Max. 300.0 µmol/mol     Detector tube                    < 300 µmol/mol

    Nitric Oxide                        Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

    Nitrogen Dioxide              Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

    Ammonia                            Max. 25.0 µmol/mol       Detector tube                    < 25 µmol/mol

    Halogens                                                                            

    (Chlorine)                            Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

    Moisture                             Max. 100.0 ppm               Detector tube                    < 100 ppm

    Capacitance

    Air                                          Max 1.0 cmol/mol            Gas Chromatograph        0.16 cmol/mol

    Identity                                Positive                                Gas Chromatograph        Positive

    La concentracion esto expresada en unidades del Sistoma Internaciona La unidad µmol/mol

    Es equivalente a porm y cmol/ mol es equivalente a %mol/mol.

    The concentration is expressed in units of the International System. The unit µmol/mol are equivalent to ppm and cmol/mol are equivalent to % mol/mol.

    Compliance with requirements:                Yes _X_ No ___

                                                                                                                                    Reviewer’s Signature:

                                                                                    ____________________________________________

                                                                                                    QI. MYRNA VEONICA CRUZ MARTINEZ

                                                                                                    Quality Control Responsible.

    IMPORTANT The information here contained it has been prepared by expert personnel of Praxair Mexico by way of orientation toward the user. The suggested analytic Techniques have demonstrated a high dependability I their results, however, the use that is given to the information it is completely user user’s exclusive responsibility. This report cannot be reportability. This report cannot be reproduced without authorization of the Laboratory of Coontrol of Quality of Product of Praxair Mexidom, S. de, R.L. de C.V., Toluca Plants.

    QQ/r-08-019/1 – P0270

    Nitrous oxide

    Close
  • INGREDIENTS AND APPEARANCE
    NITROUS OXIDE 
    nitrous oxide gas
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72223-001
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NITROUS OXIDE (UNII: K50XQU1029) (NITROUS OXIDE - UNII:K50XQU1029) NITROUS OXIDE 990 mL  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72223-001-01 7064200 L in 1 CONTAINER; Type 0: Not a Combination Product 06/08/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA210235 06/08/2017
    Labeler - Praxair Mexico, S. de R.L. de C.V (812953909)
    Establishment
    Name Address ID/FEI Business Operations
    Praxair Mexico, S. de R.L. de C.V 812953909 manufacture(72223-001)
    Close