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 firm2026-10-15

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 3 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AirAIRFresno Oxygen and Welding Suppliers, Inc.60cc8727-2b78-3cdb-e053-2991aa0a64e12025-10-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENFresno Oxygen & Welding Suppliers Inc201cee91-cd54-49b8-aa97-932d74aa004b2025-10-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENClovis Equipment & Supply Company55373dd8-3a52-439d-b4f0-649b237f57e82025-10-23Exact identifier
application applno (NDA): 205889
application number: NDA205889
RECONSTITUTED AIRRECONSTITUTED AIRWSM SUPPLIER LLC.17e3afd9-e900-1d44-e063-6294a90a04722025-10-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENCrumpton Welding Supply & Equipment, Inc.8c6b984d-2ace-4534-b441-c2db959a1da12025-02-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENEastern Welding Supply, Inc.6ee3107c-6cd3-4171-aef7-a7ac033ab3b12024-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
AIR COMPRESSEDAIR COMPRESSEDCrumpton Welding Supply & Equipment, Inc.6ab929ae-a49c-4b6b-9f66-91f3463e3ed52024-10-15Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENAMO Medical Oxygen, Inc.642ebb98-d27f-188b-e053-2a91aa0a0a692020-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENAMO Medical Oxygen, Inc.642ec89f-4ba3-68cd-e053-2991aa0a6a5c2020-10-19Exact 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