FDA.reportPublic FDA data

Oxygen

Product NDC
49798-001
11-digit product format
497980001
Labeler code
49798
Product ID
49798-001_44830028-7469-8b16-e063-6294a90a6426
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
James Oxygen and Supply Company
Application
NDA205767
Marketing category
NDA
Marketing start
1956-01-01
Substance
OXYGEN
Active strength
992 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.

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN992 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
348831Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
39d41dbb-c44c-4ef8-9de6-a4f36648f0cbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49798-001-01Oxygen424 L in 1 CYLINDERGAS42412
49798-001-02Oxygen679 L in 1 CYLINDERGAS67912
49798-001-03Oxygen7249 L in 1 CYLINDERGAS724912
49798-001-04Oxygen3539 L in 1 CYLINDERGAS353912

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [JAMES OXYGEN AND SUPPLY COMPANY]1
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [JAMES OXYGEN AND SUPPLY COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49798-001OXYGEN GAS [JAMES OXYGEN AND SUPPLY COMPANY]11Current NDC, Legacy NDC, 4 package rows20241102_39d41dbb-c44c-4ef8-9de6-a4f36648f0cb.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
348831oxygen 99.2 % Gas for InhalationPSN39d41dbb-c44c-4ef8-9de6-a4f36648f0cb12
348831oxygen 99.2 % Gas for InhalationSCD39d41dbb-c44c-4ef8-9de6-a4f36648f0cb12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49798-001-0149798000101424 L in 1 CYLINDER (49798-001-01) 424 l1956-01-010000-00-00NoNoCurrent
49798-001-0249798000102679 L in 1 CYLINDER (49798-001-02) 679 l1956-01-010000-00-00NoNoCurrent
49798-001-03497980001037249 L in 1 CYLINDER (49798-001-03) 7249 l1956-01-010000-00-00NoNoCurrent
49798-001-04497980001043539 L in 1 CYLINDER (49798-001-04) 3539 l1956-01-010000-00-00NoNoCurrent