FDA.reportPublic FDA data

Oxygen

Product NDC
57716-001
Requested package NDC
57716-001-21
11-digit product format
577160001
Labeler code
57716
Product ID
57716-001_eb407418-690a-0a79-e053-2995a90a9070
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Sky Oxygen
Application
NDA206023
Marketing category
NDA
Marketing start
2004-04-01
Marketing end
0000-00-00
Substance
OXYGEN
Active strength
990 mL/L
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 packagepackage57716-00157716-001-21DDiscontinued by firm2026-11-06

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [SKY OXYGEN]4
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [SKY OXYGEN]4

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENKENRIC INC dba Trinity Medical Supplies8b24c114-1f66-cd5f-e053-2a95a90a04d72026-01-05Exact identifier
application applno (NDA): 206023
application number: NDA206023
OXYGENOXYGENSpectrum Gas Products, Inc7084eeff-f327-490c-be27-18c8d52c609a2025-12-03Exact identifier
application applno (NDA): 206023
application number: NDA206023
Medical AirMEDICAL AIRKeen Compressed Gas Co. Inc.d7c32a52-b342-2efb-e053-2a95a90adfc52025-11-17Exact identifier
application applno (NDA): 206023
application number: NDA206023
OxygenOXYGENTerry Supply Company Incf98c83fe-37cd-4916-bdbc-74c76b9a12d32025-10-24Exact identifier
application applno (NDA): 206023
application number: NDA206023
OxygenOXYGENTechnical Gas Products, Inc.f3b9b20c-dffb-2397-e053-2995a90a238a2025-10-07Exact identifier
application applno (NDA): 206023
application number: NDA206023
OXYGENOXYGENSuperior Oxygen & Medical Equipment948a25d5-086e-4393-9c0a-78cb5037263d2024-10-28Exact identifier
application applno (NDA): 206023
application number: NDA206023
OxygenOXYGENRichmond Oxygen Company Inc.667d1826-2cd8-412e-a626-ceb8c13143132024-10-28Exact identifier
application applno (NDA): 206023
application number: NDA206023
OXYGENOXYGENJernigan Healthcare, Inc.e1e95608-832c-4b13-81d3-bd4b7e6b20732024-10-27Exact identifier
application applno (NDA): 206023
application number: NDA206023
OXYGENOXYGENBickett Machine and Supply, Inc0a436386-0a73-4b49-b234-60dd752a6a0a2024-10-12Exact identifier
application applno (NDA): 206023
application number: NDA206023
Carbon Dioxide Oxygen MixCARBON DIOXIDE OXYGEN MIXAirgas Usa, LLCefaa38b5-86b3-4f81-abb1-5f6170cb30072024-10-01Exact identifier
application applno (NDA): 206023
application number: NDA206023
Nitrogen Oxygen MixNITROGEN OXYGEN MIXAirgas Usa, LLC00dc36cc-8f26-4b05-b9b5-cb4b2fd277cf2024-10-01Exact identifier
application applno (NDA): 206023
application number: NDA206023
Medical Oxygen CompressedOXYGENMMC - Dickinson Home Medical Equipment5e6b256f-f2c1-4384-a1fa-5235d56bc6902024-07-03WarningsExact identifier
application applno (NDA): 206023
application number: NDA206023
OXYGENOXYGENMountain Aire Medical Supply, Inc70ce96f2-7825-4c3f-8606-9bca08a295ec2022-10-13Exact identifier
application applno (NDA): 206023
application number: NDA206023
Oxygen Refrigerated LiquidOXYGENElliot Hospital of the City of Manchester DBA: Home Medical Equipment and Infusion Services of Manchester & Southern N.H.a66ada71-a046-4e70-8cab-e46659722b5d2022-10-04Exact identifier
application applno (NDA): 206023
application number: NDA206023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57716-001-2157716000121303 L in 1 CYLINDER (57716-001-21) 303 l2004-04-010000-00-00NoNoCurrent