SPL v8
SPL
SPL Set ID e2b7e83b-e1ba-446b-aff9-ff7050839eff
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2024-10-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrogen (99 L)

Identifiers & Packaging

Marketing Status
NDA Active Since 2017-12-27
Description

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 Results Units Specifications 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:

Medication Information

Description

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 Results Units Specifications 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

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

Results Units Specifications

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:

Structured Label Content

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

Results Units Specifications

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:

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:31.822531 · Updated: 2026-03-14T22:15:52.273968