Nitrogen by FULLERTON WELDING SUPPLY NITROGEN gas

Nitrogen by

Drug Labeling and Warnings

Nitrogen by is a Prescription medication manufactured, distributed, or labeled by FULLERTON WELDING SUPPLY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

NITROGEN 
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42751-1073
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)	NITROGEN	990 mL  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42751-1073-1	6229.71 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
2	NDC: 42751-1073-2	7079.21 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
3	NDC: 42751-1073-4	8495.05 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
4	NDC: 42751-1073-5	3114.85 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
5	NDC: 42751-1073-6	3539.61 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
6	NDC: 42751-1073-7	424.75 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
7	NDC: 42751-1073-8	679.6 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018
8	NDC: 42751-1073-3	7928.72 L in 1 CYLINDER; Type 0: Not a Combination Product	08/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205866	08/30/2018

Labeler - FULLERTON WELDING SUPPLY (556832384)

Establishment
Name	Address	ID/FEI	Business Operations
FULLERTON WELDING SUPPLY		556832384	manufacture(42751-1073)