Label: NITROGEN gas

  • NDC Code(s): 42751-1073-1, 42751-1073-2, 42751-1073-3, 42751-1073-4, view more
    42751-1073-5, 42751-1073-6, 42751-1073-7, 42751-1073-8
  • Packager: FULLERTON WELDING SUPPLY
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 8, 2020

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  • PRINCIPAL DISPLAY PANEL

    Certificate of Analysis

    By Air-Liquefaction Process

    Product: NITROGEN NF*

    Manufacturing Plant: Pryor, OK

    Address: Hwy 69A & 412 B

    Pryor, OK 74361

    Date / Time: 8/16/2018 9:43:00 AM

    Lot Number: 037-08/16/2018/09:43

    Delivery Unit # (Tanker / Railcar): 037

    Quantity / Level / Prossure Gross: 31245 Tare: Net: LBS

    *NF/EP applies only when used in a medical application or by medical customers properly registered with the FDA

    Product delivered has been tested for indicated parameters and satisfies the contractually guaranteed purity specifications. Results are nominal values within statistical accuracy of analytical test methods.

    This certificate does not add to or replace the warranty, limitations of liablilty or other provisions of the agreement between parties.

    Requirement Test Method Specification Limit Result

    Nitrogen Diff ≥ 99.999 percent ≥ 99.999 percent

    Oxygen ** Delta F FAH0100 ≤ 5.00 ppm .68 ppm

    Odor ** Organoleptic None None

    Ppm = parts per million by volume ppb = parts per billion by volume

    *Analysis on storage tank on periodic basis

    **Analysis of each delivery unit

    Released By:

    Released via Electronic Signature: no handwritten signature required

    (Signature)

    Kevin N. Shue

    (Printed Name)

    QA-046US (08/17)

    USJS0I00239193000 AutoLand TM nitrogen

  • INGREDIENTS AND APPEARANCE
    NITROGEN 
    nitrogen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42751-1073
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN990 mL  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42751-1073-16229.71 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    2NDC:42751-1073-27079.21 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    3NDC:42751-1073-48495.05 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    4NDC:42751-1073-53114.85 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    5NDC:42751-1073-63539.61 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    6NDC:42751-1073-7424.75 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    7NDC:42751-1073-8679.6 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    8NDC:42751-1073-37928.72 L in 1 CYLINDER; Type 0: Not a Combination Product08/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20586608/30/2018
    Labeler - FULLERTON WELDING SUPPLY (556832384)
    Establishment
    NameAddressID/FEIBusiness Operations
    FULLERTON WELDING SUPPLY556832384manufacture(42751-1073)