FDA.reportPublic FDA data

Oxygen

Product NDC
84078-002
11-digit product format
840780002
Labeler code
84078
Product ID
84078-002_508742c3-256a-48a7-e063-6394a90acf3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.
Application
NDA205889
Marketing category
NDA
Marketing start
2024-01-29
Substance
OXYGEN
Active strength
992 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage84078-00284078-002-01DDiscontinued by firm2026-10-15
excluded packagepackage84078-00284078-002-09DDiscontinued by firm2026-10-15

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN992 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
348831Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1017fba9-0472-88cf-e063-6294a90afe1cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84078-002-01Oxygen8510 L in 1 CYLINDERGAS85105
84078-002-02Oxygen150 L in 1 CYLINDERGAS1505
84078-002-03Oxygen120 L in 1 CYLINDERGAS1205
84078-002-04Oxygen425 L in 1 CYLINDERGAS4255
84078-002-05Oxygen705 L in 1 CYLINDERGAS7055
84078-002-06Oxygen532 L in 1 CYLINDERGAS5325
84078-002-07Oxygen3324 L in 1 CYLINDERGAS33245
84078-002-08Oxygen6414 L in 1 CYLINDERGAS64145
84078-002-09Oxygen137100 L in 1 CYLINDERGAS1371005
84078-002-10Oxygen180 L in 1 CYLINDERGAS1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84078-002OXYGEN GAS [WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.]2Current NDC, 10 package rows20241204_1017fba9-0472-88cf-e063-6294a90afe1c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AirAIRFresno Oxygen and Welding Suppliers, Inc.60cc8727-2b78-3cdb-e053-2991aa0a64e12025-10-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENFresno Oxygen & Welding Suppliers Inc201cee91-cd54-49b8-aa97-932d74aa004b2025-10-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENClovis Equipment & Supply Company55373dd8-3a52-439d-b4f0-649b237f57e82025-10-23Exact identifier
application applno (NDA): 205889
application number: NDA205889
RECONSTITUTED AIRRECONSTITUTED AIRWSM SUPPLIER LLC.17e3afd9-e900-1d44-e063-6294a90a04722025-10-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENCrumpton Welding Supply & Equipment, Inc.8c6b984d-2ace-4534-b441-c2db959a1da12025-02-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENEastern Welding Supply, Inc.6ee3107c-6cd3-4171-aef7-a7ac033ab3b12024-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
AIR COMPRESSEDAIR COMPRESSEDCrumpton Welding Supply & Equipment, Inc.6ab929ae-a49c-4b6b-9f66-91f3463e3ed52024-10-15Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENAMO Medical Oxygen, Inc.642ebb98-d27f-188b-e053-2a91aa0a0a692020-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENAMO Medical Oxygen, Inc.642ec89f-4ba3-68cd-e053-2991aa0a6a5c2020-10-19Exact identifier
application applno (NDA): 205889
application number: NDA205889

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348831oxygen 99.2 % Gas for InhalationPSN1017fba9-0472-88cf-e063-6294a90afe1c5
348831oxygen 99.2 % Gas for InhalationSCD1017fba9-0472-88cf-e063-6294a90afe1c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84078-002-01840780002018510 L in 1 CYLINDER8510 lHistorical
84078-002-0284078000202150 L in 1 CYLINDER (84078-002-02) 150 l2024-01-29NoNoCurrent
84078-002-0384078000203120 L in 1 CYLINDER (84078-002-03) 120 l2024-01-29NoNoCurrent
84078-002-0484078000204425 L in 1 CYLINDER (84078-002-04) 425 l2024-01-29NoNoCurrent
84078-002-0584078000205705 L in 1 CYLINDER (84078-002-05) 705 l2024-01-29NoNoCurrent
84078-002-0684078000206532 L in 1 CYLINDER (84078-002-06) 532 l2024-01-29NoNoCurrent
84078-002-07840780002073324 L in 1 CYLINDER (84078-002-07) 3324 l2024-01-29NoNoCurrent
84078-002-08840780002086414 L in 1 CYLINDER (84078-002-08) 6414 l2024-01-29NoNoCurrent
84078-002-0984078000209137100 L in 1 CYLINDER137100 lHistorical
84078-002-1084078000210180 L in 1 CYLINDER (84078-002-10) 180 l2024-01-29NoNoCurrent