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 1 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.1017fba9-0472-88cf-e063-6294a90afe1c2026-04-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMITCHELL WELDING SUPPLY DBA Meritus Texas704755e8-239d-18d6-e053-2991aa0ab7d22026-03-24Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMatheson Tri-Gas, Inc.d7c5336e-3afe-2763-e053-2a95a90ae78f2026-03-13Exact identifier
application applno (NDA): 205889
application number: NDA205889
RECONSTITUTED AIRRECONSTITUTED AIRWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.497829cf-edd9-eb06-e063-6394a90a80e42026-01-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENCorrigan Propane LLC dba Blue Water Industrial Productseed9ed38-3eba-4aac-b2e8-fbfaa4549dba2026-01-25Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENPlains Welding Supply, Inc.0bfa29ff-cac6-40b5-880d-6cbf13a50c512025-12-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENHelget Gas Productsf791c94b-7fba-3857-e053-6294a90ac6be2025-12-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
AirAIRSYOXSA, Inc.0087ce2c-2c34-4a37-83e1-e0cabb87fc7c2025-12-12Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENT J Nowak Supply Co Inc94540cd6-3795-ac60-e053-2995a90afcbd2025-12-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENTIMS SOUTH TEXAS LLCbd23d80b-7ca3-4cf6-bd90-6b6ec7a1bbf92025-12-09Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENHELGET, INC.fc4d37c6-d6a1-24ef-e053-6394a90a8b0f2025-12-09Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENRotech Healthcare Inc28a03918-92a5-1bd0-e063-6394a90ab6722025-12-08Exact identifier
application applno (NDA): 205889
application number: NDA205889
Reconstituted AirRECONSTITUTED AIRHelget Gas Products436c1132-5ac9-b396-e063-6394a90adec42025-12-05Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 38/62OXYGEN/NITROGEN 38/62MATHESON TRI-GAS, INC.f5260a57-c389-3e7a-e053-2995a90a30f72025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 25/75OXYGEN/NITROGEN 25/75MATHESON TRI-GAS, INC.f5260aa2-6da8-25c6-e053-2995a90aca972025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 9.7/90.3OXYGEN/NITROGEN 9.7/90.3MATHESON TRI-GAS, INC.f52684b1-76fb-2184-e053-2a95a90adca42025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 10/90OXYGEN/NITROGEN 10/90MATHESON TRI-GAS, INC.f5254763-fef1-1b64-e053-2a95a90aa47e2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 25/75OXYGEN/HELIUM 25/75MATHESON TRI-GAS, INC.10bcb7de-ec3a-ee58-e063-6294a90a4a152025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 15/85OXYGEN/NITROGEN 15/85MATHESON TRI-GAS, INC.f525e843-6efa-25c4-e053-2995a90a9cdd2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 26/74OXYGEN/NITROGEN 26/74MATHESON TRI-GAS, INC.f5261ce4-6850-6212-e053-2995a90a42762025-12-02Exact 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