FDA.reportPublic FDA data

OXYGEN

Product NDC
48546-0001
11-digit product format
485460001
Labeler code
48546
Product ID
48546-0001_3900254d-9785-4335-b041-9841d2aca5d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYGEN
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Indiana Oxygen Company Inc
Application
NDA205767
Marketing category
NDA
Marketing start
1960-01-01
Substance
OXYGEN
Active strength
99 L/100L
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
OXYGEN99 L/100L

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312172Internal RxNorm lookup
312173Internal RxNorm lookup
312174Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a116dc52-9522-4cc3-b745-0b0cc3e0d7ddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48546-0001-1OXYGEN113 L in 1 CYLINDERGAS11313
48546-0001-2OXYGEN170 L in 1 CYLINDERGAS17013
48546-0001-3OXYGEN255 L in 1 CYLINDERGAS25513
48546-0001-4OXYGEN425 L in 1 CYLINDERGAS42513
48546-0001-5OXYGEN566 L in 1 CYLINDERGAS56613
48546-0001-6OXYGEN679 L in 1 CYLINDERGAS67913
48546-0001-7OXYGEN1132 L in 1 CYLINDERGAS113213
48546-0001-8OXYGEN3114 L in 1 CYLINDERGAS311413
48546-0001-9OXYGEN4247 L in 1 CYLINDERGAS424713

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT14065OXYGEN GAS [INDIANA OXYGEN COMPANY, INC.]1
OXYGENACTIVE MOIETYS88TT14065OXYGEN GAS [INDIANA OXYGEN COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48546-0001OXYGEN GAS [INDIANA OXYGEN COMPANY INC]13Current NDC, Legacy NDC, 9 package rows20241025_a116dc52-9522-4cc3-b745-0b0cc3e0d7dd.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
312172oxygen 99 % Gas for InhalationPSNa116dc52-9522-4cc3-b745-0b0cc3e0d7dd13
312173oxygen 99.5 % Gas for InhalationPSNa116dc52-9522-4cc3-b745-0b0cc3e0d7dd13
312174oxygen 99.6 % Gas for InhalationPSNa116dc52-9522-4cc3-b745-0b0cc3e0d7dd13
312172oxygen 99 % Gas for InhalationSCDa116dc52-9522-4cc3-b745-0b0cc3e0d7dd13
312173oxygen 99.5 % Gas for InhalationSCDa116dc52-9522-4cc3-b745-0b0cc3e0d7dd13
312174oxygen 99.6 % Gas for InhalationSCDa116dc52-9522-4cc3-b745-0b0cc3e0d7dd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48546-0001-148546000101113 L in 1 CYLINDER (48546-0001-1) 113 l1960-01-010000-00-00NoNoCurrent
48546-0001-248546000102170 L in 1 CYLINDER (48546-0001-2) 170 l1960-01-010000-00-00NoNoCurrent
48546-0001-348546000103255 L in 1 CYLINDER (48546-0001-3) 255 l1960-01-010000-00-00NoNoCurrent
48546-0001-448546000104425 L in 1 CYLINDER (48546-0001-4) 425 l1960-01-010000-00-00NoNoCurrent
48546-0001-548546000105566 L in 1 CYLINDER (48546-0001-5) 566 l1960-01-010000-00-00NoNoCurrent
48546-0001-648546000106679 L in 1 CYLINDER (48546-0001-6) 679 l1960-01-010000-00-00NoNoCurrent
48546-0001-7485460001071132 L in 1 CYLINDER (48546-0001-7) 1132 l1960-01-010000-00-00NoNoCurrent
48546-0001-8485460001083114 L in 1 CYLINDER (48546-0001-8) 3114 l1960-01-010000-00-00NoNoCurrent
48546-0001-9485460001094247 L in 1 CYLINDER (48546-0001-9) 4247 l1960-01-010000-00-00NoNoCurrent