Nitrogen by Ineos Pigments Asu LLC

Nitrogen by

Drug Labeling and Warnings

Nitrogen by is a Prescription medication manufactured, distributed, or labeled by Ineos Pigments Asu LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NITROGEN- nitrogen gas 
Ineos Pigments Asu LLC

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Nitrogen

Certificate of Analysis                    Shipped From:

                                                                                                                Ashtabula Oxygen

                                                                                                                2501 Middle Rd.

                                                                                                                Ashtabula, Ohio                              

                                                                                                                Phone: (440) 994-1994

Company Name: TEST

Product:               Nitrogen

Load No:              5                                                                                              Trailer No:          0000

Time In:               16:44:58               Time Out:            16:46:04               Load Date:          12/26/2017

Tare Weight:     0                              Gross Weight:   0           lbs           Net Weight:       0    lbs

Lot Number:      4004N17360050000                                         Produced by: Air Liquefaction

  Assay per NF requirements is by difference of O2 only

Ashtabula Oxygen

ResultsUnitsSpecifications

Purity Pre-Fill:                  PASS                                                                      Pass*

Purity Post-Fill:                99.99                     %                            >=99.999%

Assay, By Difference)

O2:                                                                         ppm/V                  <=2.0ppm

  O2 Tested By: Teledyne 3000TA-XL Electrochemcial

CO:                                                                         ppm/V                  <=5.0ppm

  CO Tested By: Teledyne GFC-7001T Non-Dispersive Infrared

H2O:                                                                      ppm/V                  <=2.0ppm

  H20 Tested By: Teledyne 8800A Electrochemcial

Odor:                                                                    None                     None

  Odor Tested By: Organoleptic

• The Pre-Fill is tested against Ashtabula Oxygen and USP/NF specification and a “Pass” indicated that the results met and exceeded the applicable specifications. The results of the Pre-Fill tests are kept on file.

Ashtabula Oxygen Analyst: I declare that this analysis was completed with all Ashtabula Oxygen policy and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

Signed:         Date/Time:

Product Release Specialist/Release By: I declare that this certification is accurate, complete and compliant with all applicable policies and procedures and that the product meets all Ashtabula Oxygen and USP/NF specifications.

Signed:         Date/Time:

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 MSDS.

Signed:         Date/Time:

NITROGEN 
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71408-002
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71408-002-01	10000 L in 1 TANK; Type 0: Not a Combination Product	12/27/2017	12/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA211737	12/27/2017	12/28/2017

Labeler - Ineos Pigments Asu LLC (080634966)

Registrant - Ineos Pigments Asu LLC (080634966)

Establishment
Name	Address	ID/FEI	Business Operations
Ineos Pigments Asu LLC		080634966	manufacture(71408-002)

Revised: 9/2019

Document Id: 5a166c18-4d3d-43ac-8601-1d9a435e0933

34391-3

Set id: 58861b8f-69d1-4465-a121-5a6fb52605ca

Version: 2

Effective Time: 20190918

 

Ineos Pigments Asu LLC