FDA.reportPublic FDA data

Oxygen

Product NDC
65386-0001
Requested package NDC
65386-0001-3
11-digit product format
653860001
Labeler code
65386
Product ID
65386-0001_ef199777-e52f-f9e7-e053-2995a90a76ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Advacare Home Services
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2009-10-28
Marketing end
0000-00-00
Substance
OXYGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65386-000165386-0001-3IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65386-0001-12026-01-29C16284748780-149896155-b7fd-586f-e063-e6dba90add90Oxygen
65386-0001-22026-01-29C16284748780-149896155-b7fd-586f-e063-e6dba90add90Oxygen
65386-0001-32026-01-29C16284748780-149896155-b7fd-586f-e063-e6dba90add90Oxygen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65386-0001-1Oxygen31 L in 1 DEWARGAS318
65386-0001-2Oxygen41 L in 1 DEWARGAS418
65386-0001-3Oxygen46 L in 1 DEWARGAS468

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65386-0001OXYGEN GAS [ADVACARE HOME SERVICES, INC.]8Legacy NDC, 3 package rows20241120_985fb6bc-3f1e-41ac-a3ae-5fe1d6251a71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN985fb6bc-3f1e-41ac-a3ae-5fe1d6251a718
312172oxygen 99 % Gas for InhalationSCD985fb6bc-3f1e-41ac-a3ae-5fe1d6251a718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65386-0001-36538600010346 L in 1 DEWAR (65386-0001-3) 46 l2009-10-280000-00-00NoNoCurrent