FDA.reportPublic FDA data

Oxygen

Product NDC
80650-001
Requested package NDC
80650-001-01
11-digit product format
806500001
Labeler code
80650
Product ID
80650-001_ea25fa82-1d12-aa62-e053-2a95a90ac88a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Pur O2 LLC
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2020-09-23
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 packagepackage80650-00180650-001-01IInactivated 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, Related label table
NDCRelated label
80650-001-01Oxygen, USP
80650-001-02Oxygen, USP
80650-001-03Oxygen, USP
80650-001-04Oxygen, USP
80650-001-05Oxygen, USP
80650-001-06Oxygen, USP
80650-001-07Oxygen, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80650-001-01Oxygen113 L in 1 CYLINDERGAS1136
80650-001-02Oxygen164 L in 1 CYLINDERGAS1646
80650-001-03Oxygen255 L in 1 CYLINDERGAS2556
80650-001-04Oxygen425 L in 1 CYLINDERGAS4256
80650-001-05Oxygen680 L in 1 CYLINDERGAS6806
80650-001-06Oxygen3455 L in 1 CYLINDERGAS34556
80650-001-07Oxygen7080 L in 1 CYLINDERGAS70806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80650-001OXYGEN GAS [PUR O2 LLC]6Legacy NDC, 7 package rows20241207_afff7cb0-87fb-d620-e053-2995a90a476a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSNafff7cb0-87fb-d620-e053-2995a90a476a6
312172oxygen 99 % Gas for InhalationSCDafff7cb0-87fb-d620-e053-2995a90a476a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80650-001-0180650000101113 L in 1 CYLINDER (80650-001-01) 113 l2020-09-230000-00-00NoNoCurrent