Nitrogen by UCG Georgia, LLC / UNIVERSAL INDUSTRIAL GASES, LLC NITROGEN gas

Nitrogen by

Drug Labeling and Warnings

Nitrogen by is a Prescription medication manufactured, distributed, or labeled by UCG Georgia, LLC, UNIVERSAL INDUSTRIAL GASES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

-

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

INGREDIENTS AND APPEARANCE

NITROGEN 
nitrogen gas

Product 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)