FDA.reportPublic FDA data

Oxygen

Product NDC
57439-003
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 · 16 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57439-003DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-01DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-02DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-03DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-04DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-05DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-06DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-07DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-08DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-09DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-10DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-11DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-12DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-13DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-14DDiscontinued by firm2026-10-05
excluded packagepackage57439-00357439-003-15DDiscontinued by firm2026-10-05

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 4 · 240 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57439-003-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57439-003-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57439-003-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57439-003-08a1b67e2a42f9…c4cf2c586c0d…

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
57439-003-0257439000302170 L in 1 CYLINDER (57439-003-02) 170 l2018-01-010000-00-00NoNoCurrent
57439-003-0357439000303255 L in 1 CYLINDER (57439-003-03) 255 l2018-01-010000-00-00NoNoCurrent
57439-003-0457439000304425 L in 1 CYLINDER (57439-003-04) 425 l2018-01-010000-00-00NoNoCurrent
57439-003-0557439000305680 L in 1 CYLINDER (57439-003-05) 680 l2018-01-010000-00-00NoNoCurrent
57439-003-06574390003061738 L in 1 CYLINDER (57439-003-06) 1738 l2018-01-010000-00-00NoNoCurrent
57439-003-07574390003072549 L in 1 CYLINDER (57439-003-07) 2549 l2018-01-010000-00-00NoNoCurrent
57439-003-08574390003083455 L in 1 CYLINDER (57439-003-08) 3455 l2018-01-010000-00-00NoNoCurrent
57439-003-09574390003097100 L in 1 CYLINDER (57439-003-09) 7100 l2018-01-010000-00-00NoNoCurrent
57439-003-10574390003109430 L in 1 CYLINDER (57439-003-10) 9430 l2018-01-010000-00-00NoNoCurrent
57439-003-115743900031120 L in 1 DEWAR (57439-003-11) 20 l2018-01-010000-00-00NoNoCurrent
57439-003-125743900031230 L in 1 DEWAR (57439-003-12) 30 l2018-01-010000-00-00NoNoCurrent
57439-003-135743900031332 L in 1 DEWAR (57439-003-13) 32 l2018-01-010000-00-00NoNoCurrent
57439-003-145743900031437 L in 1 DEWAR (57439-003-14) 37 l2018-01-010000-00-00NoNoCurrent
57439-003-155743900031545 L in 1 DEWAR (57439-003-15) 45 l2018-01-010000-00-00NoNoCurrent