Label: NITROGEN gas
- NDC Code(s): 72457-005-01
- Packager: UCG Georgia, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 17, 2022
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PRINCIPAL DISPLAY PANEL
UIG Universal Industrial Gases, Inc
Certificate of Analysis
All NF Nitrogen delivered by Universal Industrial Gases, Inc, when used in a medical application or by medical customers properly registered with the FDA, is classified as NF Nitrogen
Shipped From
Taylor Data Systems
181 E. Evans St
Suite A
Florence, SC 29505
843-656-2084
Company: Taylor Data Systems Operator: Admin
Product: Nitrogen Product Code: NI 300
Driver: Test Driver Tractor No: 14 Trailer No: 123
Load No: 92 Certificate No: 214 Tank No: 1100
Time In: 12:29 PM Time Out: 2:48 PM Certification Date: 6/4/2018 2:48 PM
Tare Weight: 10010 lbs Gross Weight: 45000 lbs Net Weight: 34990 lbs
Lot Number: TDS-155-18-N-1100-1 Produced By: TDS
Assay per NF requirements is by difference of O2 only
Results Units USP/NF Specifications TDS Specifications
Purity Pre-fill 99.9985 % >=99.9985 % >=99.9985 %
Purity Post fill 99.9992 % >=99.00 % >=99.999 %
Assay, by Difference
O2 4.00 ppm/V <=1.0 % <=5.00 ppm/V
O2-Nitrogen
CO 4.00 ppm/V <=10.0 % <=10.00 ppm/V
CO-Nitrogen
Odor None None None
Organoleptic
Identity Nitrogen Nitrogen Nitrogen
Dew Point -88.50 deg. F 0.00 deg. F
Moisture 4.00 ppm/V <=5.00 ppm/V
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Critical Analyzers Yes
*The Pre-Fill is tested against UIGI specifications and a Pass indicates that the results met or exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.
Quantity delivered to trailer: 34,990.00 Gallons: 2.04 Cubic Feet: 482966.97
UIGI Analyst: I declare that this analysis was completed within all UIGI policy and procedures and that the product meets all UIGI specifications.
Signed: Date: 06/04/2018
Product Release Specialist / Released By: I declare that this certificate is accurate, complete and compliant with all applicable policies and procedures, that all pre-fill inspections including inspection of the loading hose and connections were performed following all applicable procedures, and that the product meets all UIGI specifications.
Signed: Date: 06/04/2018
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 SDS.
Signed: Date: 06/04/2018
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INGREDIENTS AND APPEARANCE
NITROGEN
nitrogen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72457-005 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN 995 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72457-005-01 1.5819 L in 1 TANK; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA212315 11/01/2018 Labeler - UCG Georgia, LLC (107923171) Establishment Name Address ID/FEI Business Operations UCG Georgia, LLC 107923171 manufacture(72457-005) Establishment Name Address ID/FEI Business Operations UNIVERSAL INDUSTRIAL GASES, LLC 118689412 manufacture(72457-005)