FDA.reportPublic FDA data

Oxygen

Product NDC
49575-001
Requested package NDC
49575-001-01
11-digit product format
495750001
Labeler code
49575
Product ID
49575-001_4c352527-886c-372e-e063-6294a90aa1bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Machine & Welding Supply Company dba Arc3 Gases South
Application
NDA205767
Marketing category
NDA
Marketing start
1999-06-15
Substance
OXYGEN
Active strength
992 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
Oxygen
Listing expiration
2027-12-31

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
08936fbe-b98b-4a97-a99b-3e06caa15aafAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49575-001-01Oxygen103 L in 1 CYLINDERGAS10317
49575-001-02Oxygen126 L in 1 CYLINDERGAS12617
49575-001-03Oxygen150 L in 1 CYLINDERGAS15017
49575-001-04Oxygen198 L in 1 CYLINDERGAS19817
49575-001-05Oxygen226 L in 1 CYLINDERGAS22617
49575-001-06Oxygen420 L in 1 CYLINDERGAS42017
49575-001-07Oxygen588 L in 1 CYLINDERGAS58817
49575-001-08Oxygen690 L in 1 CYLINDERGAS69017
49575-001-09Oxygen1133 L in 1 CYLINDERGAS113317
49575-001-10Oxygen1567 L in 1 CYLINDERGAS156717
49575-001-11Oxygen2549 L in 1 CYLINDERGAS254917
49575-001-12Oxygen3160 L in 1 CYLINDERGAS316017
49575-001-13Oxygen3172 L in 1 CYLINDERGAS317217
49575-001-14Oxygen6270 L in 1 CYLINDERGAS627017
49575-001-15Oxygen8510 L in 1 CYLINDERGAS851017
49575-001-16Oxygen127100 L in 1 CYLINDERGAS12710017
49575-001-17Oxygen141500 L in 1 CYLINDERGAS14150017
49575-001-18Oxygen179803 L in 1 CANGAS17980317
49575-001-19Oxygen206472 L in 1 CYLINDERGAS20647217
49575-001-20Oxygen16750 L in 1 DEWARGAS1675017
49575-001-21Oxygen24950 L in 1 DEWARGAS2495017
49575-001-22Oxygen25650 L in 1 DEWARGAS2565017
49575-001-23Oxygen29069 L in 1 DEWARGAS2906917
49575-001-24Oxygen33500 L in 1 DEWARGAS3350017
49575-001-25Oxygen33620 L in 1 DEWARGAS3362017
49575-001-26Oxygen37619 L in 1 DEWARGAS3761917
49575-001-27Oxygen7760 L in 1 CYLINDERGAS776017
49575-001-28Oxygen2165 L in 1 CYLINDERGAS216517
49575-001-29Oxygen3137.5 L in 1 CYLINDERGAS3137.517
49575-001-30Oxygen3841 L in 1 CYLINDERGAS384117
49575-001-31Oxygen179803 L in 1 CYLINDERGAS17980317

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [MACHINE & WELDING SUPPLY COMPANY]5
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [MACHINE & WELDING SUPPLY COMPANY]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49575-001OXYGEN GAS [MACHINE & WELDING SUPPLY COMPANY DBA ARC3 GASES SOUTH]15Current NDC, Legacy NDC, 31 package rows20241208_08936fbe-b98b-4a97-a99b-3e06caa15aaf.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 InhalationPSN08936fbe-b98b-4a97-a99b-3e06caa15aaf17
348831oxygen 99.2 % Gas for InhalationSCD08936fbe-b98b-4a97-a99b-3e06caa15aaf17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49575-001-0149575000101103 L in 1 CYLINDER (49575-001-01) 103 l1999-06-150000-00-00NoNoCurrent