FDA.reportPublic FDA data

Oxygen

Product NDC
54528-001
Requested package NDC
54528-001-04
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
2027-12-31

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
06bd1b09-21f1-6e1e-e054-00144ff8d46cAvailable on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENCommonwealth Home Health Care, Inc.06bd1b09-21f1-6e1e-e054-00144ff8d46c2026-06-08Exact identifier
ndc (package): 54528-001-04
ndc (product): 54528-001
ndc11 (package): 54528000104

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
54528-001-04545280001043540 L in 1 CYLINDER (54528-001-04) 3540 l2014-10-310000-00-00NoNoCurrent