FDA.reportPublic FDA data

Nitrogen

Manufacturer
Ineos Pigments ASU LLC
Effective date
2024-10-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 21:15:50

Label at a glance#

ProductNitrogen
Active ingredientNITROGEN
Label structure1 sections

Label contents#

Full prescribing information#

Nitrogen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 COANitrogen COA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311998nitrogen 99 % Gas for InhalationPSN8
311998nitrogen 99 % Gas for InhalationSCD8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71408-003-01Nitrogen10000 L in 1 TANKGAS100008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71408-003NITROGEN GAS [INEOS PIGMENTS ASU LLC]8Current NDC, Legacy NDC, 1 package rows20241029_e2b7e83b-e1ba-446b-aff9-ff7050839eff.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71408-00371408-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
NITROGENN762921K75ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENIneos Pigments ASU LLCe2b7e83b-e1ba-446b-aff9-ff7050839eff2024-10-27Exact identifier
ndc (package): 71408-003-01
ndc (product): 71408-003
ndc11 (package): 71408000301
spl id: 6ba04b65-16ed-479e-b28b-973e61faf4e5
spl set id: e2b7e83b-e1ba-446b-aff9-ff7050839eff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.