FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
53440-003
11-digit product format
534400003
Labeler code
53440
Product ID
53440-003_4487d01b-70d3-2154-e063-6394a90ad85e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Westair Gases & Equipment, Inc.
Application
NDA206009
Marketing category
NDA
Marketing start
2000-01-01
Substance
NITROUS OXIDE
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
Nitrous Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROUS OXIDE995 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK50XQU1029
Rxcui347046

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53440-003-01Nitrous Oxide13815 L in 1 CYLINDERGAS1381515
53440-003-02Nitrous Oxide7400 L in 1 CYLINDERGAS740015
53440-003-03Nitrous Oxide4934 L in 1 CYLINDERGAS493415
53440-003-04Nitrous Oxide1653 L in 1 CYLINDERGAS165315
53440-003-05Nitrous Oxide863 L in 1 CYLINDERGAS86315
53440-003-06Nitrous Oxide711 L in 1 CYLINDERGAS71115
53440-003-07Nitrous Oxide1337 L in 1 CYLINDERGAS133715
53440-003-08Nitrous Oxide5167 L in 1 CYLINDERGAS516715
53440-003-09Nitrous Oxide14163 L in 1 CYLINDERGAS1416315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [WESTAIR GASES & EQUIPMENT, INC.]2
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [WESTAIR GASES & EQUIPMENT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53440-003NITROUS OXIDE GAS [WESTAIR GASES & EQUIPMENT, INC.]14Current NDC, Legacy NDC, 9 package rows20250409_ec885e73-b328-4bbb-90bf-728ec9517ad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347046nitrous oxide 99.5 % Gas for InhalationPSNec885e73-b328-4bbb-90bf-728ec9517ad715
347046nitrous oxide 99.5 % Gas for InhalationSCDec885e73-b328-4bbb-90bf-728ec9517ad715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53440-003-015344000030113815 L in 1 CYLINDER (53440-003-01) 13815 l2000-01-010000-00-00NoNoCurrent
53440-003-02534400003027400 L in 1 CYLINDER (53440-003-02) 7400 l2000-01-010000-00-00NoNoCurrent
53440-003-03534400003034934 L in 1 CYLINDER (53440-003-03) 4934 l2000-01-010000-00-00NoNoCurrent
53440-003-04534400003041653 L in 1 CYLINDER (53440-003-04) 1653 l2000-01-010000-00-00NoNoCurrent
53440-003-0553440000305863 L in 1 CYLINDER (53440-003-05) 863 l2000-01-010000-00-00NoNoCurrent
53440-003-0653440000306711 L in 1 CYLINDER (53440-003-06) 711 l2000-01-01NoNoCurrent
53440-003-07534400003071337 L in 1 CYLINDER (53440-003-07) 1337 l2000-01-01NoNoCurrent
53440-003-08534400003085167 L in 1 CYLINDER (53440-003-08) 5167 l2000-01-01NoNoCurrent
53440-003-095344000030914163 L in 1 CYLINDER (53440-003-09) 14163 l2000-01-01NoNoCurrent