FDA.reportPublic FDA data

Oxygen

Product NDC
66365-001
11-digit product format
663650001
Labeler code
66365
Product ID
66365-001_40aa5b41-8930-6e56-e063-6294a90a2210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Medical Comfort Systems Inc
Application
NDA205849
Marketing category
NDA
Marketing start
2001-06-01
Substance
OXYGEN
Active strength
998 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
OXYGEN998 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui348381

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66365-001-01Oxygen70 L in 1 CYLINDERGAS7013
66365-001-02Oxygen248 L in 1 CYLINDERGAS24813
66365-001-03Oxygen415 L in 1 CYLINDERGAS41513
66365-001-04Oxygen682 L in 1 CYLINDERGAS68213
66365-001-05Oxygen1724 L in 1 CYLINDERGAS172413
66365-001-06Oxygen3452 L in 1 CYLINDERGAS345213
66365-001-07Oxygen16750 L in 1 DEWARGAS1675013
66365-001-08Oxygen24950 L in 1 DEWARGAS2495013
66365-001-09Oxygen29069 L in 1 DEWARGAS2906913
66365-001-10Oxygen33500 L in 1 DEWARGAS3350013
66365-001-11Oxygen37619 L in 1 DEWARGAS3761913
66365-001-12Oxygen38300 L in 1 DEWARGAS3830013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66365-001OXYGEN GAS [MEDICAL COMFORT SYSTEMS INC]12Current NDC, Legacy NDC, 12 package rows20241204_9f9cb81e-1f28-4091-8a69-17eb6a3bc1c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348381oxygen 99.8 % Gas for InhalationPSN9f9cb81e-1f28-4091-8a69-17eb6a3bc1c313
348381oxygen 99.8 % Gas for InhalationSCD9f9cb81e-1f28-4091-8a69-17eb6a3bc1c313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66365-001-016636500010170 L in 1 CYLINDER (66365-001-01) 70 l2001-06-010000-00-00NoNoCurrent
66365-001-0266365000102248 L in 1 CYLINDER (66365-001-02) 248 l2001-06-010000-00-00NoNoCurrent
66365-001-0366365000103415 L in 1 CYLINDER (66365-001-03) 415 l2001-06-010000-00-00NoNoCurrent
66365-001-0466365000104682 L in 1 CYLINDER (66365-001-04) 682 l2001-06-010000-00-00NoNoCurrent
66365-001-05663650001051724 L in 1 CYLINDER (66365-001-05) 1724 l2001-06-010000-00-00NoNoCurrent
66365-001-06663650001063452 L in 1 CYLINDER (66365-001-06) 3452 l2001-06-010000-00-00NoNoCurrent
66365-001-076636500010716750 L in 1 DEWAR (66365-001-07) 16750 l2001-06-010000-00-00NoNoCurrent
66365-001-086636500010824950 L in 1 DEWAR (66365-001-08) 24950 l2001-06-010000-00-00NoNoCurrent
66365-001-096636500010929069 L in 1 DEWAR (66365-001-09) 29069 l2001-06-010000-00-00NoNoCurrent
66365-001-106636500011033500 L in 1 DEWAR (66365-001-10) 33500 l2001-06-010000-00-00NoNoCurrent
66365-001-116636500011137619 L in 1 DEWAR (66365-001-11) 37619 l2001-06-010000-00-00NoNoCurrent
66365-001-126636500011238300 L in 1 DEWAR (66365-001-12) 38300 l2001-06-010000-00-00NoNoCurrent