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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57439-003		D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-01	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-02	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-03	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-04	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-05	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-06	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-07	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-08	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-09	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-10	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-11	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-12	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-13	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-14	D	Discontinued by firm	2026-10-05
excluded package	package	57439-003	57439-003-15	D	Discontinued by firm	2026-10-05

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57439-003-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57439-003-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57439-003-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57439-003-08	`a1b67e2a42f9…`	`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
NDC	Effective	Related label
57439-003-01	2025-02-01	Oxygen
57439-003-02	2025-02-01	Oxygen
57439-003-03	2025-02-01	Oxygen
57439-003-04	2025-02-01	Oxygen
57439-003-05	2025-02-01	Oxygen
57439-003-06	2025-02-01	Oxygen
57439-003-07	2025-02-01	Oxygen
57439-003-08	2025-02-01	Oxygen
57439-003-09	2025-02-01	Oxygen
57439-003-10	2025-02-01	Oxygen
57439-003-11	2025-02-01	Oxygen
57439-003-12	2025-02-01	Oxygen
57439-003-13	2025-02-01	Oxygen
57439-003-14	2025-02-01	Oxygen
57439-003-15	2025-02-01	Oxygen
57439-003-01	2023-07-28	Oxygen
57439-003-02	2023-07-28	Oxygen
57439-003-03	2023-07-28	Oxygen
57439-003-04	2023-07-28	Oxygen
57439-003-05	2023-07-28	Oxygen
57439-003-06	2023-07-28	Oxygen
57439-003-07	2023-07-28	Oxygen
57439-003-08	2023-07-28	Oxygen
57439-003-09	2023-07-28	Oxygen
57439-003-10	2023-07-28	Oxygen
57439-003-11	2023-07-28	Oxygen
57439-003-12	2023-07-28	Oxygen
57439-003-13	2023-07-28	Oxygen
57439-003-14	2023-07-28	Oxygen
57439-003-15	2023-07-28	Oxygen

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Air	AIR	Fresno Oxygen and Welding Suppliers, Inc.	60cc8727-2b78-3cdb-e053-2991aa0a64e1	2025-10-28	Exact identifier application applno (NDA): 205889 application number: NDA205889
Oxygen	OXYGEN	Fresno Oxygen & Welding Suppliers Inc	201cee91-cd54-49b8-aa97-932d74aa004b	2025-10-28	Exact identifier application applno (NDA): 205889 application number: NDA205889
OXYGEN	OXYGEN	Clovis Equipment & Supply Company	55373dd8-3a52-439d-b4f0-649b237f57e8	2025-10-23	Exact identifier application applno (NDA): 205889 application number: NDA205889
RECONSTITUTED AIR	RECONSTITUTED AIR	WSM SUPPLIER LLC.	17e3afd9-e900-1d44-e063-6294a90a0472	2025-10-10	Exact identifier application applno (NDA): 205889 application number: NDA205889
OXYGEN	OXYGEN	Crumpton Welding Supply & Equipment, Inc.	8c6b984d-2ace-4534-b441-c2db959a1da1	2025-02-10	Exact identifier application applno (NDA): 205889 application number: NDA205889
OXYGEN	OXYGEN	Eastern Welding Supply, Inc.	6ee3107c-6cd3-4171-aef7-a7ac033ab3b1	2024-10-19	Exact identifier application applno (NDA): 205889 application number: NDA205889
AIR COMPRESSED	AIR COMPRESSED	Crumpton Welding Supply & Equipment, Inc.	6ab929ae-a49c-4b6b-9f66-91f3463e3ed5	2024-10-15	Exact identifier application applno (NDA): 205889 application number: NDA205889
Oxygen	OXYGEN	AMO Medical Oxygen, Inc.	642ebb98-d27f-188b-e053-2a91aa0a0a69	2020-10-19	Exact identifier application applno (NDA): 205889 application number: NDA205889
Oxygen	OXYGEN	AMO Medical Oxygen, Inc.	642ec89f-4ba3-68cd-e053-2991aa0a6a5c	2020-10-19	Exact identifier application applno (NDA): 205889 application number: NDA205889

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S88TT14065	OXYGEN	7782-44-7	OXYGEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57439-003-01	57439000301	113 L in 1 CYLINDER (57439-003-01)	113 l	2018-01-01	0000-00-00	No	No	Current
57439-003-02	57439000302	170 L in 1 CYLINDER (57439-003-02)	170 l	2018-01-01	0000-00-00	No	No	Current
57439-003-03	57439000303	255 L in 1 CYLINDER (57439-003-03)	255 l	2018-01-01	0000-00-00	No	No	Current
57439-003-04	57439000304	425 L in 1 CYLINDER (57439-003-04)	425 l	2018-01-01	0000-00-00	No	No	Current
57439-003-05	57439000305	680 L in 1 CYLINDER (57439-003-05)	680 l	2018-01-01	0000-00-00	No	No	Current
57439-003-06	57439000306	1738 L in 1 CYLINDER (57439-003-06)	1738 l	2018-01-01	0000-00-00	No	No	Current
57439-003-07	57439000307	2549 L in 1 CYLINDER (57439-003-07)	2549 l	2018-01-01	0000-00-00	No	No	Current
57439-003-08	57439000308	3455 L in 1 CYLINDER (57439-003-08)	3455 l	2018-01-01	0000-00-00	No	No	Current
57439-003-09	57439000309	7100 L in 1 CYLINDER (57439-003-09)	7100 l	2018-01-01	0000-00-00	No	No	Current
57439-003-10	57439000310	9430 L in 1 CYLINDER (57439-003-10)	9430 l	2018-01-01	0000-00-00	No	No	Current
57439-003-11	57439000311	20 L in 1 DEWAR (57439-003-11)	20 l	2018-01-01	0000-00-00	No	No	Current
57439-003-12	57439000312	30 L in 1 DEWAR (57439-003-12)	30 l	2018-01-01	0000-00-00	No	No	Current
57439-003-13	57439000313	32 L in 1 DEWAR (57439-003-13)	32 l	2018-01-01	0000-00-00	No	No	Current
57439-003-14	57439000314	37 L in 1 DEWAR (57439-003-14)	37 l	2018-01-01	0000-00-00	No	No	Current
57439-003-15	57439000315	45 L in 1 DEWAR (57439-003-15)	45 l	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxygen	Rotech Healthcare Inc \| ROTECH \| RHEMA MEDICAL \| Oxygen Plus, Inc. dba Summit Respiratory \| HEARTLAND HOME HEALTH CARE \| MAJOR MEDICAL \| COMMUNITY HOME OXYGEN \| ROTECH HOME MEDICAL CARE \| FIRST CARE \| ROTECH OF ARLINGTON HEIGHTS \| MAJOR MEDICAL SUPPLY \| KELLEY'S HOME HEALTH SERVICES \| G&G MEDICAL \| SUMMIT RESPIRATORY \| CPO2 \| HOME CARE MEDICAL SERVICES \| Sentry Home Health \| ROTH MEDICAL \| CAMBRIA MEDICAL SUPPLY \| HOME MEDICAL SYSTEMS \| FAMILY HOME CARE \| GREAT LAKES HOME MEDICAL \| MED-AIR TRANSFILL \| VITALCARE HEALTH SERVICES	2022-06-15	HUMAN PRESCRIPTION DRUG LABEL	2