FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
22557-003
11-digit product format
225570003
Labeler code
22557
Product ID
22557-003_42ccd446-2035-2a33-e063-6294a90a85b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
AGP LLC
Application
NDA206009
Marketing category
NDA
Marketing start
2024-02-15
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
22557-003-01Nitrous Oxide265 L in 1 CANGAS2652
22557-003-02Nitrous Oxide18600 L in 1 CYLINDERGAS186002
22557-003-03Nitrous Oxide14163 L in 1 CYLINDERGAS141632
22557-003-04Nitrous Oxide5167 L in 1 CYLINDERGAS51672
22557-003-05Nitrous Oxide711 L in 1 CYLINDERGAS7112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22557-003NITROUS OXIDE GAS [AGP LLC]1Current NDC, 5 package rows20241102_25c59b03-863d-f108-e063-6294a90ac454.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSN25c59b03-863d-f108-e063-6294a90ac4542
312022nitrous oxide 99 % Gas for InhalationSCD25c59b03-863d-f108-e063-6294a90ac4542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
22557-003-0122557000301265 L in 1 CAN (22557-003-01) 265 l2024-02-15NoNoHistorical
22557-003-022255700030218600 L in 1 CYLINDER (22557-003-02) 18600 l2024-02-15NoNoHistorical
22557-003-032255700030314163 L in 1 CYLINDER (22557-003-03) 14163 l2024-02-15NoNoHistorical
22557-003-04225570003045167 L in 1 CYLINDER (22557-003-04) 5167 l2024-02-15NoNoHistorical
22557-003-0522557000305711 L in 1 CYLINDER (22557-003-05) 711 l2024-02-15NoNoHistorical