Home NDC 57439-005-08 Oxygen
Product NDC 57439-005
Requested package NDC 57439-005-08
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.
DailyMed Package Descriptions# 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 1 of 3 · 49 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Oxygen OXYGEN WELDERS SUPPLY COMPANY OF LOUISVILLE, INC. 1017fba9-0472-88cf-e063-6294a90afe1c 2026-04-28 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN MITCHELL WELDING SUPPLY DBA Meritus Texas 704755e8-239d-18d6-e053-2991aa0ab7d2 2026-03-24 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN Matheson Tri-Gas, Inc. d7c5336e-3afe-2763-e053-2a95a90ae78f 2026-03-13 Exact identifier application applno (NDA): 205889 application number: NDA205889 RECONSTITUTED AIR RECONSTITUTED AIR WELDERS SUPPLY COMPANY OF LOUISVILLE, INC. 497829cf-edd9-eb06-e063-6394a90a80e4 2026-01-28 Exact identifier application applno (NDA): 205889 application number: NDA205889 OXYGEN OXYGEN Corrigan Propane LLC dba Blue Water Industrial Products eed9ed38-3eba-4aac-b2e8-fbfaa4549dba 2026-01-25 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN Plains Welding Supply, Inc. 0bfa29ff-cac6-40b5-880d-6cbf13a50c51 2025-12-28 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN Helget Gas Products f791c94b-7fba-3857-e053-6294a90ac6be 2025-12-19 Exact identifier application applno (NDA): 205889 application number: NDA205889 Air AIR SYOXSA, Inc. 0087ce2c-2c34-4a37-83e1-e0cabb87fc7c 2025-12-12 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN T J Nowak Supply Co Inc 94540cd6-3795-ac60-e053-2995a90afcbd 2025-12-10 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN TIMS SOUTH TEXAS LLC bd23d80b-7ca3-4cf6-bd90-6b6ec7a1bbf9 2025-12-09 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN HELGET, INC. fc4d37c6-d6a1-24ef-e053-6394a90a8b0f 2025-12-09 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen OXYGEN Rotech Healthcare Inc 28a03918-92a5-1bd0-e063-6394a90ab672 2025-12-08 Exact identifier application applno (NDA): 205889 application number: NDA205889 ndc (package): 57439-005-08 ndc (product): 57439-005 ndc11 (package): 57439000508 Reconstituted Air RECONSTITUTED AIR Helget Gas Products 436c1132-5ac9-b396-e063-6394a90adec4 2025-12-05 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Nitrogen 38/62 OXYGEN/NITROGEN 38/62 MATHESON TRI-GAS, INC. f5260a57-c389-3e7a-e053-2995a90a30f7 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Nitrogen 25/75 OXYGEN/NITROGEN 25/75 MATHESON TRI-GAS, INC. f5260aa2-6da8-25c6-e053-2995a90aca97 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Nitrogen 9.7/90.3 OXYGEN/NITROGEN 9.7/90.3 MATHESON TRI-GAS, INC. f52684b1-76fb-2184-e053-2a95a90adca4 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Nitrogen 10/90 OXYGEN/NITROGEN 10/90 MATHESON TRI-GAS, INC. f5254763-fef1-1b64-e053-2a95a90aa47e 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Helium 25/75 OXYGEN/HELIUM 25/75 MATHESON TRI-GAS, INC. 10bcb7de-ec3a-ee58-e063-6294a90a4a15 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Nitrogen 15/85 OXYGEN/NITROGEN 15/85 MATHESON TRI-GAS, INC. f525e843-6efa-25c4-e053-2995a90a9cdd 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889 Oxygen/Nitrogen 26/74 OXYGEN/NITROGEN 26/74 MATHESON TRI-GAS, INC. f5261ce4-6850-6212-e053-2995a90a4276 2025-12-02 Exact identifier application applno (NDA): 205889 application number: NDA205889
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 57439-005-08 57439000508 3455 L in 1 CYLINDER (57439-005-08) 3455 l 2018-01-01 No No Current