FDA.reportPublic FDA data

Oxygen

Manufacturer
Ineos Pigments ASU LLC
Effective date
2024-10-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:15:49

Label at a glance#

ProductOxygen
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

Oxygen COA

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:               Oxygen

Load No:              6                                                                                              Trailer No:          0000

Time In:               16:56:01               Time Out:            16:56:38               Load Date:          12/26/2017

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

Lot Number:      4004O17360060000                                         Produced by: Air Liquefaction

Ashtabula Oxygen

ResultsUnitsSpecifications

Purity Pre-Fill:                  PASS                                                                      Pass*

Purity Post-Fill:                99.99                     %                            >=99.6%

Assay, Tested By: Teledyne 3010MA Paramagnetic

  • 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:

                                                                                                                                                                TF-0001-O Rev.1

Oxygen COAOxygen COA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312172oxygen 99 % Gas for InhalationPSN7
312172oxygen 99 % Gas for InhalationSCD7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71408-001-01Oxygen10000 L in 1 TANKGAS100007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71408-001OXYGEN GAS [INEOS PIGMENTS ASU LLC]7Current NDC, Legacy NDC, 1 package rows20241029_d130e778-a02c-4762-b09a-85358e0994ce.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
71408-00171408-001-01

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
OXYGENS88TT14065ACTIB

Source Document#

Source XML · Source PDF

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
OxygenOXYGENIneos Pigments ASU LLCd130e778-a02c-4762-b09a-85358e0994ce2024-10-27Exact identifier
ndc (package): 71408-001-01
ndc (product): 71408-001
ndc11 (package): 71408000101
spl id: ee8e7c08-b7f2-45c6-8813-4b79921b464b
spl set id: d130e778-a02c-4762-b09a-85358e0994ce

Reported adverse events (FAERS/openFDA)#

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