FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
43621-003
11-digit product format
436210003
Labeler code
43621
Product ID
43621-003_44713b93-5146-fa19-e063-6294a90a6cbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
DJB Gas Services, Inc
Application
NDA205704
Marketing category
NDA
Marketing start
2016-09-12
Substance
NITROUS OXIDE
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
Nitrous Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROUS OXIDE990 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK50XQU1029
Rxcui312022

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43621-003-11Nitrous Oxide198 L in 1 CYLINDERGAS19818
43621-003-12Nitrous Oxide255 L in 1 CYLINDERGAS25518
43621-003-13Nitrous Oxide425 L in 1 CYLINDERGAS42518
43621-003-14Nitrous Oxide708 L in 1 CYLINDERGAS70818
43621-003-15Nitrous Oxide1133 L in 1 CYLINDERGAS113318
43621-003-16Nitrous Oxide1614 L in 1 CYLINDERGAS161418
43621-003-17Nitrous Oxide2265 L in 1 CYLINDERGAS226518
43621-003-18Nitrous Oxide3539 L in 1 CYLINDERGAS353918
43621-003-19Nitrous Oxide7108 L in 1 CYLINDERGAS710818
43621-003-20Nitrous Oxide9543 L in 1 CYLINDERGAS954318
43621-003-21Nitrous Oxide180 L in 1 DEWARGAS18018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43621-003NITROUS OXIDE GAS [DJB GAS SERVICES, INC]17Current NDC, Legacy NDC, 11 package rows20241023_403d8fa6-0c7a-4b87-a654-e0bb39c14327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSN403d8fa6-0c7a-4b87-a654-e0bb39c1432718
312022nitrous oxide 99 % Gas for InhalationSCD403d8fa6-0c7a-4b87-a654-e0bb39c1432718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43621-003-1143621000311198 L in 1 CYLINDER (43621-003-11) 198 l2016-09-120000-00-00NoNoCurrent
43621-003-1243621000312255 L in 1 CYLINDER (43621-003-12) 255 l2016-09-120000-00-00NoNoCurrent
43621-003-1343621000313425 L in 1 CYLINDER (43621-003-13) 425 l2016-09-120000-00-00NoNoCurrent
43621-003-1443621000314708 L in 1 CYLINDER (43621-003-14) 708 l2016-09-120000-00-00NoNoCurrent
43621-003-15436210003151133 L in 1 CYLINDER (43621-003-15) 1133 l2016-09-120000-00-00NoNoCurrent
43621-003-16436210003161614 L in 1 CYLINDER (43621-003-16) 1614 l2016-09-120000-00-00NoNoCurrent
43621-003-17436210003172265 L in 1 CYLINDER (43621-003-17) 2265 l2016-09-120000-00-00NoNoCurrent
43621-003-18436210003183539 L in 1 CYLINDER (43621-003-18) 3539 l2016-09-120000-00-00NoNoCurrent
43621-003-19436210003197108 L in 1 CYLINDER (43621-003-19) 7108 l2016-09-120000-00-00NoNoCurrent
43621-003-20436210003209543 L in 1 CYLINDER (43621-003-20) 9543 l2016-09-120000-00-00NoNoCurrent
43621-003-2143621000321180 L in 1 DEWAR (43621-003-21) 180 l2016-09-120000-00-00NoNoCurrent