Oxygen

Product NDC: 57439-005
Requested package NDC: 57439-005-01
11-digit product format: 574390005
Labeler code: 57439
Product ID: 57439-005_4575be56-6759-e922-e063-6294a90a8867
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
Substance: OXYGEN
Active strength: 990 mL/L
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: Oxygen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYGEN	990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S88TT14065	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312172	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
28a03918-92a5-1bd0-e063-6394a90ab672	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57439-005-01	Oxygen	113 L in 1 CYLINDER	GAS	113	4
57439-005-02	Oxygen	170 L in 1 CYLINDER	GAS	170	4
57439-005-03	Oxygen	255 L in 1 CYLINDER	GAS	255	4
57439-005-04	Oxygen	425 L in 1 CYLINDER	GAS	425	4
57439-005-05	Oxygen	680 L in 1 CYLINDER	GAS	680	4
57439-005-06	Oxygen	1738 L in 1 CYLINDER	GAS	1738	4
57439-005-07	Oxygen	2549 L in 1 CYLINDER	GAS	2549	4
57439-005-08	Oxygen	3455 L in 1 CYLINDER	GAS	3455	4
57439-005-09	Oxygen	7100 L in 1 CYLINDER	GAS	7100	4
57439-005-10	Oxygen	9430 L in 1 CYLINDER	GAS	9430	4
57439-005-11	Oxygen	20 L in 1 DEWAR	GAS	20	4
57439-005-12	Oxygen	30 L in 1 DEWAR	GAS	30	4
57439-005-13	Oxygen	32 L in 1 DEWAR	GAS	32	4
57439-005-14	Oxygen	37 L in 1 DEWAR	GAS	37	4
57439-005-15	Oxygen	45 L in 1 DEWAR	GAS	45	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57439-005	OXYGEN GAS [ROTECH HEALTHCARE INC]	3	Current NDC, 15 package rows	20250305_28a03918-92a5-1bd0-e063-6394a90ab672.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312172	oxygen 99 % Gas for Inhalation	PSN	28a03918-92a5-1bd0-e063-6394a90ab672	4
312172	oxygen 99 % Gas for Inhalation	SCD	28a03918-92a5-1bd0-e063-6394a90ab672	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
57439-005-01	57439000501	113 L in 1 CYLINDER (57439-005-01)	113 l	2018-01-01	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 \| CARE MEDICAL SUPPLIES, INC. dba Rotech of Arlington Heights \| MAJOR MEDICAL SUPPLY \| KELLEY'S HOME HEALTH SERVICES \| G&G MEDICAL \| RESPONSIVE HOME HEALTH CARE, INC. dba ROTECH \| SUMMIT RESPIRATORY \| CPO2 \| HOME CARE MEDICAL SERVICES \| Sentry Home Health \| ROTH MEDICAL \| CAMBRIA MEDICAL SUPPLY \| HOME MEDICAL SYSTEMS \| Community Home Oxygen, Inc. \| MMS Norfolk, Inc. \| FAMILY HOME CARE \| GREAT LAKES HOME MEDICAL \| MED-AIR TRANSFILL \| VITALCARE HEALTH SERVICES	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	4