FDA.reportPublic FDA data

Oxygen

Product NDC
57439-003
Requested package NDC
57439-003-01
11-digit product format
574390003
Labeler code
57439
Product ID
57439-003_e1815a46-4ee7-2786-e053-2a95a90a7094
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Rotech Healthcare Inc
Application
NDA205889
Marketing category
NDA
Marketing start
2018-01-01
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 packagepackage57439-00357439-003-01DDiscontinued by firm2026-10-12

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57439-003-012025-02-01Oxygen
57439-003-022025-02-01Oxygen
57439-003-032025-02-01Oxygen
57439-003-042025-02-01Oxygen
57439-003-052025-02-01Oxygen
57439-003-062025-02-01Oxygen
57439-003-072025-02-01Oxygen
57439-003-082025-02-01Oxygen
57439-003-092025-02-01Oxygen
57439-003-102025-02-01Oxygen
57439-003-112025-02-01Oxygen
57439-003-122025-02-01Oxygen
57439-003-132025-02-01Oxygen
57439-003-142025-02-01Oxygen
57439-003-152025-02-01Oxygen
57439-003-012023-07-28Oxygen
57439-003-022023-07-28Oxygen
57439-003-032023-07-28Oxygen
57439-003-042023-07-28Oxygen
57439-003-052023-07-28Oxygen
57439-003-062023-07-28Oxygen
57439-003-072023-07-28Oxygen
57439-003-082023-07-28Oxygen
57439-003-092023-07-28Oxygen
57439-003-102023-07-28Oxygen
57439-003-112023-07-28Oxygen
57439-003-122023-07-28Oxygen
57439-003-132023-07-28Oxygen
57439-003-142023-07-28Oxygen
57439-003-152023-07-28Oxygen

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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxygen/Nitrogen 12/88OXYGEN/NITROGEN 12/88MATHESON TRI-GAS, INC.f525d24f-5008-93aa-e053-2a95a90acbcb2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 30/70OXYGEN/NITROGEN 30/70MATHESON TRI-GAS, INC.f5262a2b-6bd4-4615-e053-2995a90aaf582025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 52/48OXYGEN/NITROGEN 52/48MATHESON TRI-GAS, INC.f5266e8f-60fb-cd73-e053-2995a90a021d2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 50/50OXYGEN/NITROGEN 50/50MATHESON TRI-GAS, INC.f5266223-b40d-6c48-e053-2995a90a39122025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 40/60OXYGEN/NITROGEN 40/60MATHESON TRI-GAS, INC.f52647f0-aba5-501d-e053-2995a90a94642025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 40/60OXYGEN/HELIUM 40/60MATHESON TRI-GAS, INC.10bcc7cd-ce72-5e9d-e063-6394a90a17e22025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 5/95OXYGEN/NITROGEN 5/95MATHESON TRI-GAS, INC.f526545f-712a-6c4a-e053-2995a90abab02025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 75/25OXYGEN/NITROGEN 75/25MATHESON TRI-GAS, INC.f526707a-f4cd-37af-e053-2995a90a85242025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Carbon Dioxide/Oxygen 5/95CARBON DIOXIDE/OXYGEN 5/95MATHESON TRI-GAS, INC.10bcb4be-21f8-0683-e063-6294a90a50362025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 20/80OXYGEN/HELIUM 20/80MATHESON TRI-GAS, INC.10bcb79f-9346-5b4c-e063-6394a90a0c262025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Carbon Dioxide OxygenCARBON DIOXIDE OXYGENMATHESON TRI-GAS, INC.10bca54e-777c-03f5-e063-6294a90aed2c2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 50/50OXYGEN/HELIUM 50/50MATHESON TRI-GAS, INC.10bcc7cd-ce75-5e9d-e063-6394a90a17e22025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 21/79OXYGEN/NITROGEN 21/79MATHESON TRI-GAS, INC.f5255f85-970d-43c7-e053-2995a90ac4362025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 30/70OXYGEN/HELIUM 30/70MATHESON TRI-GAS, INC.10bcca0f-1f2b-1163-e063-6294a90af1862025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENVolunteer Welding Supply Inc2e9baf05-c0d3-4361-82c3-e18a5bca8cd12025-11-26Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENIsland Supply Welding Co Inc9a84e50c-504a-4e7d-8595-ebce7d78d1272025-11-21Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC82316046-e3e0-7b8d-e053-2a91aa0aa69b2025-11-18Exact identifier
application applno (NDA): 205889
application number: NDA205889
AirAIRGeneral Distributing Company60cf6286-12d5-24a1-e053-2991aa0a9d742025-11-14Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENGeneral Distributing Co.ffa52347-b223-4ff8-acaa-1462f2dfb5282025-11-14Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENModern Supply Company, Inc.4a1cddbc-27f1-4a7c-b2de-5158bddf3efd2025-10-30Exact identifier
application applno (NDA): 205889
application number: NDA205889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57439-003-0157439000301113 L in 1 CYLINDER (57439-003-01) 113 l2018-01-010000-00-00NoNoCurrent