FDA.reportPublic FDA data

Oxygen

Product NDC
50063-001
11-digit product format
500630001
Labeler code
50063
Product ID
50063-001_426518bd-9cc4-0d24-e063-6294a90a3649
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Andy-Oxy Co., Inc.
Application
NDA205767
Marketing category
NDA
Marketing start
2007-01-01
Substance
OXYGEN
Active strength
995 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
OXYGEN995 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
312173Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
265e287a-1dca-4f5b-98db-c98be97bc811Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50063-001-01Oxygen368 L in 1 CYLINDERGAS36816
50063-001-02Oxygen623 L in 1 CYLINDERGAS62316
50063-001-03Oxygen99 L in 1 CYLINDERGAS9916
50063-001-04Oxygen156 L in 1 CYLINDERGAS15616
50063-001-05Oxygen235 L in 1 CYLINDERGAS23516
50063-001-06Oxygen3455 L in 1 CYLINDERGAS345516
50063-001-07Oxygen1699 L in 1 CYLINDERGAS169916
50063-001-08Oxygen2379 L in 1 CYLINDERGAS237916
50063-001-09Oxygen4248 L in 1 CYLINDERGAS424816
50063-001-10Oxygen6909 L in 1 CYLINDERGAS690916
50063-001-11Oxygen9345 L in 1 CYLINDERGAS934516
50063-001-12Oxygen137054 L in 1 DEWARGAS13705416

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [ANDY-OXY CO., INC.]5
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [ANDY-OXY CO., INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50063-001OXYGEN GAS [ANDY-OXY CO., INC.]15Current NDC, Legacy NDC, 12 package rows20241012_265e287a-1dca-4f5b-98db-c98be97bc811.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 InhalationPSN265e287a-1dca-4f5b-98db-c98be97bc81116
312173oxygen 99.5 % Gas for InhalationSCD265e287a-1dca-4f5b-98db-c98be97bc81116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50063-001-0150063000101368 L in 1 CYLINDER (50063-001-01) 368 l2007-01-010000-00-00NoNoCurrent
50063-001-0250063000102623 L in 1 CYLINDER (50063-001-02) 623 l2007-01-010000-00-00NoNoCurrent
50063-001-035006300010399 L in 1 CYLINDER (50063-001-03) 99 l2007-01-010000-00-00NoNoCurrent
50063-001-0450063000104156 L in 1 CYLINDER (50063-001-04) 156 l2007-01-010000-00-00NoNoCurrent
50063-001-0550063000105235 L in 1 CYLINDER (50063-001-05) 235 l2007-01-010000-00-00NoNoCurrent
50063-001-06500630001063455 L in 1 CYLINDER (50063-001-06) 3455 l2007-01-010000-00-00NoNoCurrent
50063-001-07500630001071699 L in 1 CYLINDER (50063-001-07) 1699 l2007-01-010000-00-00NoNoCurrent
50063-001-08500630001082379 L in 1 CYLINDER (50063-001-08) 2379 l2007-01-010000-00-00NoNoCurrent
50063-001-09500630001094248 L in 1 CYLINDER (50063-001-09) 4248 l2007-01-010000-00-00NoNoCurrent
50063-001-10500630001106909 L in 1 CYLINDER (50063-001-10) 6909 l2007-01-010000-00-00NoNoCurrent
50063-001-11500630001119345 L in 1 CYLINDER (50063-001-11) 9345 l2007-01-010000-00-00NoNoCurrent
50063-001-1250063000112137054 L in 1 DEWAR (50063-001-12) 137054 l2007-01-010000-00-00NoNoCurrent