FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
63978-201
11-digit product format
639780201
Labeler code
63978
Product ID
63978-201_458681a4-40a2-aeb4-e063-6294a90afa5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Quality Air Products Inc
Application
NDA206009
Marketing category
NDA
Marketing start
2009-01-01
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
63978-201-01Nitrous Oxide2 L in 1 CYLINDERGAS218
63978-201-02Nitrous Oxide7 L in 1 CYLINDERGAS718
63978-201-03Nitrous Oxide20 L in 1 CYLINDERGAS2018
63978-201-04Nitrous Oxide30 L in 1 CYLINDERGAS3018
63978-201-05Nitrous Oxide56 L in 1 CYLINDERGAS5618

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROUS OXIDEACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [AIR SUPPLY OF NORTH TEXAS]7
NITROUS OXIDEACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [AIR SUPPLY OF NORTH TEXAS]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63978-201NITROUS OXIDE GAS [AIR SUPPLY OF NORTH TEXAS]16Current NDC, Legacy NDC, 5 package rows20241114_044d220f-99fc-49ba-b4ad-18ff54d805f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSN044d220f-99fc-49ba-b4ad-18ff54d805f118
312022nitrous oxide 99 % Gas for InhalationSCD044d220f-99fc-49ba-b4ad-18ff54d805f118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63978-201-01639780201012 L in 1 CYLINDER (63978-201-01) 2 l2009-01-010000-00-00NoNoCurrent
63978-201-02639780201027 L in 1 CYLINDER (63978-201-02) 7 l2009-01-010000-00-00NoNoCurrent
63978-201-036397802010320 L in 1 CYLINDER (63978-201-03) 20 l2009-01-010000-00-00NoNoCurrent
63978-201-046397802010430 L in 1 CYLINDER (63978-201-04) 30 l2009-01-010000-00-00NoNoCurrent
63978-201-056397802010556 L in 1 CYLINDER (63978-201-05) 56 l2009-01-010000-00-00NoNoCurrent