FDA.reportPublic FDA data

NITROUS OXIDE

Product NDC
48273-002
11-digit product format
482730002
Labeler code
48273
Product ID
48273-002_43d1a2eb-7ea2-2816-e063-6294a90a34b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROUS OXIDE
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Keen Compressed Gas Co. Inc.
Application
NDA206009
Marketing category
NDA
Marketing start
2019-01-01
Substance
NITROUS OXIDE
Active strength
99 L/100L
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 OXIDE99 L/100L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK50XQU1029
Rxcui312022

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48273-002-04NITROUS OXIDE1632 L in 1 CYLINDERGAS163214
48273-002-05NITROUS OXIDE4880 L in 1 CYLINDERGAS488014
48273-002-06NITROUS OXIDE7447 L in 1 CYLINDERGAS744714
48273-002-07NITROUS OXIDE13800 L in 1 CYLINDERGAS1380014
48273-002-08NITROUS OXIDE940 L in 1 CYLINDERGAS94014
48273-002-09NITROUS OXIDE257 L in 1 CYLINDERGAS25714

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROUS OXIDEACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [KEEN COMPRESSED GAS CO. INC.]3
NITROUS OXIDEACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [KEEN COMPRESSED GAS CO. INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48273-002NITROUS OXIDE GAS [KEEN COMPRESSED GAS CO. INC.]13Current NDC, Legacy NDC, 6 package rows20241012_cdefd579-5acb-45e0-a743-61426a7d2615.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSNcdefd579-5acb-45e0-a743-61426a7d261514
312022nitrous oxide 99 % Gas for InhalationSCDcdefd579-5acb-45e0-a743-61426a7d261514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48273-002-04482730002041632 L in 1 CYLINDER (48273-002-04) 1632 l2019-01-010000-00-00NoNoCurrent
48273-002-05482730002054880 L in 1 CYLINDER (48273-002-05) 4880 l2019-01-010000-00-00NoNoCurrent
48273-002-06482730002067447 L in 1 CYLINDER (48273-002-06) 7447 l2019-01-010000-00-00NoNoCurrent
48273-002-074827300020713800 L in 1 CYLINDER (48273-002-07) 13800 l2019-01-010000-00-00NoNoCurrent
48273-002-0848273000208940 L in 1 CYLINDER (48273-002-08) 940 l2019-01-010000-00-00NoNoCurrent
48273-002-0948273000209257 L in 1 CYLINDER (48273-002-09) 257 l2019-01-010000-00-00NoNoCurrent