FDA.reportPublic FDA data

Oxygen

Product NDC
64395-0001
Requested package NDC
64395-0001-3
11-digit product format
643950001
Labeler code
64395
Product ID
64395-0001_472dfd7a-34b3-973b-e063-6394a90a7951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Pacific Island Medical, Inc.
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2009-12-23
Substance
OXYGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2026-12-31
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
dfcc57ba-4b9f-458c-9b8a-7ab4f3e68eb2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64395-0001-1Oxygen165 L in 1 CYLINDERGAS16517
64395-0001-2Oxygen415 L in 1 CYLINDERGAS41517
64395-0001-3Oxygen682 L in 1 CYLINDERGAS68217
64395-0001-4Oxygen3532 L in 1 CYLINDERGAS353217

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [PACIFIC ISLAND MEDICAL, INC.]1
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [PACIFIC ISLAND MEDICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64395-0001OXYGEN GAS [PACIFIC ISLAND MEDICAL, INC.]16Current NDC, Legacy NDC, 4 package rows20241228_dfcc57ba-4b9f-458c-9b8a-7ab4f3e68eb2.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
OxygenOXYGENPacific Island Medical, Inc.dfcc57ba-4b9f-458c-9b8a-7ab4f3e68eb22025-12-30Exact identifier
ndc (package): 64395-0001-3
ndc (product): 64395-0001
ndc11 (package): 64395000103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSNdfcc57ba-4b9f-458c-9b8a-7ab4f3e68eb217
312172oxygen 99 % Gas for InhalationSCDdfcc57ba-4b9f-458c-9b8a-7ab4f3e68eb217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64395-0001-364395000103682 L in 1 CYLINDER (64395-0001-3) 682 l2009-12-230000-00-00NoNoCurrent