FDA.reportPublic FDA data

Oxygen

Product NDC
69125-001
Requested package NDC
69125-001-09
11-digit product format
691250001
Labeler code
69125
Product ID
69125-001_5fdb91f1-c0fd-7a05-e063-6294a90aea47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Penn Highlands Home Medical Equipment, LLC
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2014-07-21
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
2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c13af2a-5c6e-42ea-a0f8-ab23e62844ccAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69125-001-01Oxygen682 L in 1 CYLINDERGAS68218
69125-001-02Oxygen425 L in 1 CYLINDERGAS42518
69125-001-03Oxygen255 L in 1 CYLINDERGAS25518
69125-001-04Oxygen164 L in 1 CYLINDERGAS16418
69125-001-05Oxygen113 L in 1 CYLINDERGAS11318
69125-001-06Oxygen1738 L in 1 CYLINDERGAS173818
69125-001-08Oxygen165 L in 1 CYLINDERGAS16518
69125-001-09Oxygen640 L in 1 CYLINDERGAS64018
69125-001-11Oxygen40 L in 1 DEWARGAS4018
69125-001-12Oxygen45 L in 1 DEWARGAS4518
69125-001-13Oxygen36 L in 1 DEWARGAS3618
69125-001-14Oxygen3454 L in 1 CYLINDERGAS345418
69125-001-17Oxygen46 L in 1 DEWARGAS4618

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [SMP HOME MEDICAL]1
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [SMP HOME MEDICAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69125-001OXYGEN GAS [PENN HIGHLANDS HOME MEDICAL EQUIPMENT, LLC]17Current NDC, Legacy NDC, 13 package rows20241208_7c13af2a-5c6e-42ea-a0f8-ab23e62844cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN7c13af2a-5c6e-42ea-a0f8-ab23e62844cc18
312172oxygen 99 % Gas for InhalationSCD7c13af2a-5c6e-42ea-a0f8-ab23e62844cc18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69125-001-0969125000109640 L in 1 CYLINDER (69125-001-09) 640 l2014-07-210000-00-00NoNoCurrent