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

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 Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui312173

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

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