FDA.reportPublic FDA data

Oxygen

Product NDC
61398-0828
Requested package NDC
61398-0828-6
11-digit product format
613980828
Labeler code
61398
Product ID
61398-0828_5efcd43c-a41c-edce-e063-6394a90a4d0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Complete Care Inc
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2009-12-02
Substance
OXYGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 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
950da03f-dfc3-bdb5-e053-2995a90ab33dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
61398-0828-1Oxygen, USP
61398-0828-2Oxygen, USP
61398-0828-3Oxygen, USP
61398-0828-4Oxygen, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61398-0828-0Oxygen3455 L in 1 CYLINDERGAS34558
61398-0828-5Oxygen170 L in 1 CYLINDERGAS1708
61398-0828-6Oxygen255 L in 1 CYLINDERGAS2558
61398-0828-7Oxygen425 L in 1 CYLINDERGAS4258
61398-0828-8Oxygen680 L in 1 CYLINDERGAS6808
61398-0828-9Oxygen1738 L in 1 CYLINDERGAS17388

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [COMPLETE CARE INC]1
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [COMPLETE CARE INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61398-0828OXYGEN GAS [COMPLETE CARE INC ]9Current NDC, Legacy NDC20181128_5eb002b0-4412-400b-aa77-47880319198b.zip
61398-0828OXYGEN GAS [COMPLETE CARE INC]7Current NDC, Legacy NDC, 6 package rows20241123_950da03f-dfc3-bdb5-e053-2995a90ab33d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN950da03f-dfc3-bdb5-e053-2995a90ab33d8
312172oxygen 99 % Gas for InhalationSCD950da03f-dfc3-bdb5-e053-2995a90ab33d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61398-0828-661398082806255 L in 1 CYLINDER (61398-0828-6) 255 l2009-12-020000-00-00NoNoCurrent