FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
46362-003
11-digit product format
463620003
Labeler code
46362
Product ID
46362-003_4a2f48b9-8be5-327c-e063-6294a90ad295
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Red Ball Oxygen Co., Inc.
Application
NDA206009
Marketing category
NDA
Marketing start
1986-01-01
Substance
NITROUS OXIDE
Active strength
992 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrous Oxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROUS OXIDE992 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK50XQU1029
Rxcui347166

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46362-003-01Nitrous Oxide300 L in 1 CYLINDERGAS30021
46362-003-02Nitrous Oxide4929 L in 1 CYLINDERGAS492921
46362-003-03Nitrous Oxide1590 L in 1 CYLINDERGAS159021
46362-003-04Nitrous Oxide1591 L in 1 CYLINDERGAS159121
46362-003-05Nitrous Oxide13846 L in 1 CYLINDERGAS1384621
46362-003-06Nitrous Oxide2733 L in 1 CYLINDERGAS273321
46362-003-07Nitrous Oxide959 L in 1 CYLINDERGAS95921

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [RED BALL OXYGEN CO., INC.]5
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [RED BALL OXYGEN CO., INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46362-003NITROUS OXIDE GAS [RED BALL OXYGEN CO., INC.]19Current NDC, Legacy NDC, 7 package rows20241120_02a3cf7f-d0a5-4edd-bc84-d9162558434b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347166nitrous oxide 99.2 % Gas for InhalationPSN02a3cf7f-d0a5-4edd-bc84-d9162558434b21
347166nitrous oxide 99.2 % Gas for InhalationSCD02a3cf7f-d0a5-4edd-bc84-d9162558434b21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46362-003-0146362000301300 L in 1 CYLINDER (46362-003-01) 300 l1986-01-010000-00-00NoNoCurrent
46362-003-02463620003024929 L in 1 CYLINDER (46362-003-02) 4929 l1986-01-010000-00-00NoNoCurrent
46362-003-03463620003031590 L in 1 CYLINDER (46362-003-03) 1590 l1986-01-010000-00-00NoNoCurrent
46362-003-04463620003041591 L in 1 CYLINDER (46362-003-04) 1591 l1986-01-010000-00-00NoNoCurrent
46362-003-054636200030513846 L in 1 CYLINDER (46362-003-05) 13846 l1986-01-010000-00-00NoNoCurrent
46362-003-06463620003062733 L in 1 CYLINDER (46362-003-06) 2733 l1986-01-010000-00-00NoNoCurrent
46362-003-0746362000307959 L in 1 CYLINDER (46362-003-07) 959 l1986-01-010000-00-00NoNoCurrent