FDA.reportPublic FDA data

Oxygen

Product NDC
49479-722
11-digit product format
494790722
Labeler code
49479
Product ID
49479-722_4731b44d-9c59-f02a-e063-6394a90aa9f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Linde Canada Inc.
Application
NDA205986
Marketing category
NDA
Marketing start
2013-06-28
Substance
OXYGEN
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product
Yes
Brand name base
Oxygen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312172Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae2013c3-a153-4eb3-9168-01d0b5df7ad0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49479-722-02Oxygen18000 L in 1 TANKGAS1800023

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [PRAXAIR CANADA, INC.]2
OXYGENACTIVE MOIETYS88TT14065OXYGEN GAS [PRAXAIR CANADA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49479-722OXYGEN GAS [LINDE CANADA INC.]22Current NDC, Legacy NDC, 1 package rows20241226_ae2013c3-a153-4eb3-9168-01d0b5df7ad0.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENLinde Canada Inc.ae2013c3-a153-4eb3-9168-01d0b5df7ad02025-12-30Exact identifier
application applno (NDA): 205986
application number: NDA205986
ndc (product): 49479-722

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSNae2013c3-a153-4eb3-9168-01d0b5df7ad023
312172oxygen 99 % Gas for InhalationSCDae2013c3-a153-4eb3-9168-01d0b5df7ad023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49479-722-024947907220218000 L in 1 TANK (49479-722-02) 18000 l2013-06-280000-00-00NoNoCurrent