FDA.reportPublic FDA data

Oxygen

Product NDC
42389-001
11-digit product format
423890001
Labeler code
42389
Product ID
42389-001_426653f5-af9b-b791-e063-6294a90ab914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Carepro Health Risk Management
Application
NDA205840
Marketing category
NDA
Marketing start
2007-12-01
Substance
OXYGEN
Active strength
990 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
OXYGEN990 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui312172

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42389-001-01Oxygen113 L in 1 CYLINDERGAS11313
42389-001-02Oxygen170 L in 1 CYLINDERGAS17013
42389-001-03Oxygen248 L in 1 CYLINDERGAS24813
42389-001-04Oxygen415 L in 1 CYLINDERGAS41513
42389-001-05Oxygen682 L in 1 CYLINDERGAS68213
42389-001-06Oxygen1724 L in 1 CYLINDERGAS172413
42389-001-07Oxygen3452 L in 1 CYLINDERGAS345213
42389-001-08Oxygen6910 L in 1 CYLINDERGAS691013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT14065OXYGEN GAS [CAREPRO HEALTH RISK MANAGEMENT]3
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [CAREPRO HEALTH RISK MANAGEMENT]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42389-001OXYGEN GAS [CAREPRO HEALTH RISK MANAGEMENT]12Current NDC, Legacy NDC, 8 package rows20241023_79b3a2f5-db50-4c48-a5c9-3e4ccc92ae9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN79b3a2f5-db50-4c48-a5c9-3e4ccc92ae9e13
312172oxygen 99 % Gas for InhalationSCD79b3a2f5-db50-4c48-a5c9-3e4ccc92ae9e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42389-001-0142389000101113 L in 1 CYLINDER (42389-001-01) 113 l2007-12-010000-00-00NoNoCurrent
42389-001-0242389000102170 L in 1 CYLINDER (42389-001-02) 170 l2007-12-010000-00-00NoNoCurrent
42389-001-0342389000103248 L in 1 CYLINDER (42389-001-03) 248 l2007-12-010000-00-00NoNoCurrent
42389-001-0442389000104415 L in 1 CYLINDER (42389-001-04) 415 l2007-12-010000-00-00NoNoCurrent
42389-001-0542389000105682 L in 1 CYLINDER (42389-001-05) 682 l2007-12-010000-00-00NoNoCurrent
42389-001-06423890001061724 L in 1 CYLINDER (42389-001-06) 1724 l2007-12-010000-00-00NoNoCurrent
42389-001-07423890001073452 L in 1 CYLINDER (42389-001-07) 3452 l2007-12-010000-00-00NoNoCurrent
42389-001-08423890001086910 L in 1 CYLINDER (42389-001-08) 6910 l2007-12-010000-00-00NoNoCurrent