FDA.reportPublic FDA data

Oxygen

Product NDC
53440-001
Requested package NDC
53440-001-01
11-digit product format
534400001
Labeler code
53440
Product ID
53440-001_5dd2a958-8068-7977-e063-6294a90aa715
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Westair Gases & Equipment, Inc.
Application
NDA205767
Marketing category
NDA
Marketing start
2000-01-01
Substance
OXYGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53440-00153440-001-01DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53440-00153440-001-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53440-00153440-001-01DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Oxygen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN995 mL/L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53440-001-01Oxygen230 L in 1 DEWARGAS23036
53440-001-02Oxygen180 L in 1 DEWARGAS18036
53440-001-03Oxygen160 L in 1 DEWARGAS16036
53440-001-04Oxygen33984 L in 1 CYLINDERGAS3398436
53440-001-05Oxygen8496 L in 1 CYLINDERGAS849636
53440-001-06Oxygen5664 L in 1 CYLINDERGAS566436
53440-001-07Oxygen2832 L in 1 CYLINDERGAS283236
53440-001-08Oxygen2266 L in 1 CYLINDERGAS226636
53440-001-09Oxygen1416 L in 1 CYLINDERGAS141636
53440-001-10Oxygen708 L in 1 CYLINDERGAS70836
53440-001-11Oxygen425 L in 1 CYLINDERGAS42536
53440-001-12Oxygen255 L in 1 CYLINDERGAS25536
53440-001-13Oxygen170 L in 1 CYLINDERGAS17036
53440-001-14Oxygen113 L in 1 CYLINDERGAS11336
53440-001-15Oxygen57 L in 1 CYLINDERGAS5736
53440-001-16Oxygen420 L in 1 CYLINDERGAS42036
53440-001-17Oxygen690 L in 1 CYLINDERGAS69036
53440-001-18Oxygen552 L in 1 CYLINDERGAS55236
53440-001-19Oxygen2165 L in 1 CYLINDERGAS216536
53440-001-20Oxygen3160 L in 1 CYLINDERGAS316036
53440-001-21Oxygen248.4 L in 1 CYLINDERGAS248.436
53440-001-22Oxygen4229 L in 1 CYLINDERGAS422936
53440-001-23Oxygen5270 L in 1 CYLINDERGAS527036
53440-001-24Oxygen5810 L in 1 CYLINDERGAS581036
53440-001-25Oxygen31620 L in 1 CYLINDERGAS3162036

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [WESTAIR GASES & EQUIPMENT, INC. ]10
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [WESTAIR GASES & EQUIPMENT, INC. ]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53440-001OXYGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]35Current NDC, Legacy NDC, 25 package rows20250409_899be502-55ba-4795-9e75-78951d6e7aeb.zip

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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENNoble Gas Solutions, Inc.13ce9fe8-ca43-4564-87b2-f8e97570dcfd2024-10-06Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENADF Welding & Medical, Inc.01efe36d-5281-4ede-bc30-9a1727a86a832024-10-02Exact identifier
application applno (NDA): 205767
application number: NDA205767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312173oxygen 99.5 % Gas for InhalationPSN899be502-55ba-4795-9e75-78951d6e7aeb36
312173oxygen 99.5 % Gas for InhalationSCD899be502-55ba-4795-9e75-78951d6e7aeb36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53440-001-0153440000101230 L in 1 DEWAR (53440-001-01) 230 l2000-01-010000-00-00NoNoCurrent