FDA.reportPublic FDA data

Oxygen

Product NDC
54528-001
11-digit product format
545280001
Labeler code
54528
Product ID
54528-001_3f7a30a7-1442-4e3a-e063-6294a90ae1a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Commonwealth Home Health Care, Inc.
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2014-10-31
Substance
OXYGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui312173

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54528-001-01Oxygen165 L in 1 CYLINDERGAS16530
54528-001-02Oxygen395 L in 1 CYLINDERGAS39530
54528-001-03Oxygen655 L in 1 CYLINDERGAS65530
54528-001-04Oxygen3540 L in 1 CYLINDERGAS354030
54528-001-05Oxygen7960 L in 1 CYLINDERGAS796030
54528-001-06Oxygen30 L in 1 DEWARGAS3030
54528-001-07Oxygen40 L in 1 DEWARGAS4030
54528-001-08Oxygen1699 L in 1 CYLINDERGAS169930
54528-001-09Oxygen36 L in 1 DEWARGAS3630
54528-001-10Oxygen46 L in 1 DEWARGAS4630

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT14065OXYGEN GAS [COMMONWEALTH HOME HEALTH CARE, INC.]8
OXYGENACTIVE MOIETYS88TT14065OXYGEN GAS [COMMONWEALTH HOME HEALTH CARE, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54528-001OXYGEN GAS [COMMONWEALTH HOME HEALTH CARE, INC.]28Current NDC, Legacy NDC, 10 package rows20241011_06bd1b09-21f1-6e1e-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312173oxygen 99.5 % Gas for InhalationPSN06bd1b09-21f1-6e1e-e054-00144ff8d46c30
312173oxygen 99.5 % Gas for InhalationSCD06bd1b09-21f1-6e1e-e054-00144ff8d46c30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54528-001-0154528000101165 L in 1 CYLINDER (54528-001-01) 165 l2014-10-310000-00-00NoNoCurrent
54528-001-0254528000102395 L in 1 CYLINDER (54528-001-02) 395 l2014-10-310000-00-00NoNoCurrent
54528-001-0354528000103655 L in 1 CYLINDER (54528-001-03) 655 l2014-10-310000-00-00NoNoCurrent
54528-001-04545280001043540 L in 1 CYLINDER (54528-001-04) 3540 l2014-10-310000-00-00NoNoCurrent
54528-001-05545280001057960 L in 1 CYLINDER (54528-001-05) 7960 l2014-10-310000-00-00NoNoCurrent
54528-001-065452800010630 L in 1 DEWAR (54528-001-06) 30 l2014-10-310000-00-00NoNoCurrent
54528-001-075452800010740 L in 1 DEWAR (54528-001-07) 40 l2014-10-310000-00-00NoNoCurrent
54528-001-08545280001081699 L in 1 CYLINDER (54528-001-08) 1699 l2014-10-310000-00-00NoNoCurrent
54528-001-095452800010936 L in 1 DEWAR (54528-001-09) 36 l2014-10-310000-00-00NoNoCurrent
54528-001-105452800011046 L in 1 DEWAR (54528-001-10) 46 l2014-10-310000-00-00NoNoCurrent