FDA.reportPublic FDA data

Oxygen

Product NDC
53425-001
11-digit product format
534250001
Labeler code
53425
Product ID
53425-001_4573f0fc-d580-3f16-e063-6394a90ae433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
IWS Gas and Supply of Texas, LTD
Application
NDA205712
Marketing category
NDA
Marketing start
2010-07-19
Substance
OXYGEN
Active strength
995 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.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN995 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
312173Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c21fefc5-2696-4268-b88c-452a9abb7012Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53425-001-01Oxygen7108 L in 1 CYLINDERGAS710817
53425-001-02Oxygen708 L in 1 CYLINDERGAS70817
53425-001-03Oxygen425 L in 1 CYLINDERGAS42517
53425-001-04Oxygen172365 L in 1 DEWARGAS17236517
53425-001-05Oxygen198 L in 1 CYLINDERGAS19817
53425-001-06Oxygen3228 L in 1 CYLINDERGAS322817
53425-001-07Oxygen3539 L in 1 CYLINDERGAS353917
53425-001-08Oxygen6456 L in 1 CYLINDERGAS645617
53425-001-09Oxygen7249 L in 1 CYLINDERGAS724917
53425-001-10Oxygen7957 L in 1 CYLINDERGAS795717
53425-001-11Oxygen8693 L in 1 CYLINDERGAS869317
53425-001-12Oxygen9543 L in 1 CYLINDERGAS954317
53425-001-13Oxygen180 L in 1 DEWARGAS18017
53425-001-14Oxygen200 L in 1 DEWARGAS20017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]6
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53425-001OXYGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]16Current NDC, Legacy NDC, 14 package rows20241030_c21fefc5-2696-4268-b88c-452a9abb7012.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 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AirAIRDJB Gas Services, Ince640add5-d7aa-4a10-be07-180747c320172026-02-26Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENDJB Gas Services, Incc75bd7d5-fb17-4072-885d-0915e1282de52026-02-26Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENArcet Equipment Company dba Arc3 Gases Northf0c5afcb-4e3c-44b6-9b20-409169a161aa2025-12-29Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENSYOXSA, Inc.347f107c-b1a9-4dda-9087-6d242f2e18f02025-12-12Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENQuality Air Products Inc2417965c-31f1-4448-828a-679c0e59b7582025-12-09Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENIWS Gas and Supply of Texas, LTDc21fefc5-2696-4268-b88c-452a9abb70122025-12-08Exact identifier
application applno (NDA): 205712
application number: NDA205712
ndc (product): 53425-001
OxygenOXYGENGas and Supply4d3ac73f-4970-4b7d-abfc-96844198525b2025-12-03Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENSuper Gas, Inc.c48907a0-3242-403e-abd8-283930252da92025-11-26Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENB & J Welding Supply, LTD. dba B & J Welding Supply60de398b-c254-5a8f-e053-2a91aa0aaa992025-11-14Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENB & J WELDING SUPPLY, LTD. dba B & J Welding Supply60de032e-6757-74c6-e053-2a91aa0a84cb2025-11-14Exact identifier
application applno (NDA): 205712
application number: NDA205712
AirAIRCentral Welding Supply Company123929b7-5cec-470b-96c8-2a23fd67021e2025-10-28Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENCentral Welding Supply Company2d8b3ad7-19fd-4dce-a1de-991840e4277a2025-10-28Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENHARTMAN BROTHERS, INC.b8a4f8fa-2c11-4ee4-850d-d1ee80fb00002025-10-24Exact identifier
application applno (NDA): 205712
application number: NDA205712
AirAIRHARTMAN BROTHERS, INC.adfef098-8edc-4434-a89f-1bf1038dcd7f2025-10-24Exact identifier
application applno (NDA): 205712
application number: NDA205712
OXYGENOXYGENAirtec Gases, LLCb987aa29-71ce-4062-be6c-9400a42751fa2025-10-13Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENGIBBS WELDING SUPPLY, INC.e45865b3-d888-401d-8fc9-e9272b4f79c22025-10-08Exact identifier
application applno (NDA): 205712
application number: NDA205712
OxygenOXYGENEureka Oxygen Company0b776546-e469-41cd-b9d6-d9f6b9e698902025-10-07Exact identifier
application applno (NDA): 205712
application number: NDA205712

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312173oxygen 99.5 % Gas for InhalationPSNc21fefc5-2696-4268-b88c-452a9abb701217
312173oxygen 99.5 % Gas for InhalationSCDc21fefc5-2696-4268-b88c-452a9abb701217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53425-001-01534250001017108 L in 1 CYLINDER (53425-001-01) 7108 l2010-07-190000-00-00NoNoCurrent
53425-001-0253425000102708 L in 1 CYLINDER (53425-001-02) 708 l2010-07-190000-00-00NoNoCurrent
53425-001-0353425000103425 L in 1 CYLINDER (53425-001-03) 425 l2010-07-190000-00-00NoNoCurrent
53425-001-0453425000104172365 L in 1 DEWAR (53425-001-04) 172365 l2010-07-190000-00-00NoNoCurrent
53425-001-0553425000105198 L in 1 CYLINDER (53425-001-05) 198 l2010-07-190000-00-00NoNoCurrent
53425-001-06534250001063228 L in 1 CYLINDER (53425-001-06) 3228 l2010-07-190000-00-00NoNoCurrent
53425-001-07534250001073539 L in 1 CYLINDER (53425-001-07) 3539 l2010-07-190000-00-00NoNoCurrent
53425-001-08534250001086456 L in 1 CYLINDER (53425-001-08) 6456 l2010-07-190000-00-00NoNoCurrent
53425-001-09534250001097249 L in 1 CYLINDER (53425-001-09) 7249 l2010-07-190000-00-00NoNoCurrent
53425-001-10534250001107957 L in 1 CYLINDER (53425-001-10) 7957 l2010-07-190000-00-00NoNoCurrent
53425-001-11534250001118693 L in 1 CYLINDER (53425-001-11) 8693 l2010-07-190000-00-00NoNoCurrent
53425-001-12534250001129543 L in 1 CYLINDER (53425-001-12) 9543 l2010-07-190000-00-00NoNoCurrent
53425-001-1353425000113180 L in 1 DEWAR (53425-001-13) 180 l2010-07-190000-00-00NoNoCurrent
53425-001-1453425000114200 L in 1 DEWAR (53425-001-14) 200 l2010-07-190000-00-00NoNoCurrent