FDA.reportPublic FDA data

Air

Product NDC
53440-007
Requested package NDC
53440-007-07
11-digit product format
534400007
Labeler code
53440
Product ID
53440-007_5dd28e02-13d4-b74d-e063-6394a90a0000
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Air
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

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
Air
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
53440-007-01Air33980 L in 1 CYLINDERGAS3398012
53440-007-02Air8496 L in 1 CYLINDERGAS849612
53440-007-03Air5664 L in 1 CYLINDERGAS566412
53440-007-04Air2832 L in 1 CYLINDERGAS283212
53440-007-05Air651 L in 1 CYLINDERGAS65112
53440-007-06Air408 L in 1 CYLINDERGAS40812
53440-007-07Air665 L in 1 CYLINDERGAS66512
53440-007-08Air5376 L in 1 CYLINDERGAS537612
53440-007-09Air8807 L in 1 CYLINDERGAS880712
53440-007-10Air33980 L in 1 CYLINDERGAS3398012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53440-007AIR GAS [WESTAIR GASES & EQUIPMENT, INC.]11Current NDC, Legacy NDC, 10 package rows20250409_60e0a8b9-1a9c-f98c-e053-2a91aa0ab1d3.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 InhalationPSN60e0a8b9-1a9c-f98c-e053-2a91aa0ab1d312
312173oxygen 99.5 % Gas for InhalationSCD60e0a8b9-1a9c-f98c-e053-2a91aa0ab1d312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53440-007-0753440000707665 L in 1 CYLINDER (53440-007-07) 665 l2000-01-01NoNoCurrent