FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
46123-006
11-digit product format
461230006
Labeler code
46123
Product ID
46123-006_43cf24ff-e7f5-6b53-e063-6394a90a8008
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Roberts Oxygen Company, Inc.
Application
NDA206009
Marketing category
NDA
Marketing start
1967-01-01
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
46123-006-01Nitrous Oxide247 L in 1 CYLINDERGAS24712
46123-006-02Nitrous Oxide990 L in 1 CYLINDERGAS99012
46123-006-03Nitrous Oxide1232 L in 1 CYLINDERGAS123212
46123-006-04Nitrous Oxide1590 L in 1 CYLINDERGAS159012
46123-006-05Nitrous Oxide2464 L in 1 CYLINDERGAS246412
46123-006-06Nitrous Oxide3710 L in 1 CYLINDERGAS371012
46123-006-07Nitrous Oxide4944 L in 1 CYLINDERGAS494412
46123-006-08Nitrous Oxide7391 L in 1 CYLINDERGAS739112
46123-006-09Nitrous Oxide7570 L in 1 CYLINDERGAS757012
46123-006-10Nitrous Oxide13797 L in 1 CYLINDERGAS1379712
46123-006-11Nitrous Oxide16066 L in 1 CYLINDERGAS1606612

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [ROBERTS OXYGEN COMPANY, INC.]1
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [ROBERTS OXYGEN COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46123-006NITROUS OXIDE GAS [ROBERTS OXYGEN COMPANY, INC.]9Current NDC, Legacy NDC, 11 package rows20241120_988190eb-1449-482c-8120-c1d1390e2442.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSN988190eb-1449-482c-8120-c1d1390e244212
312022nitrous oxide 99 % Gas for InhalationSCD988190eb-1449-482c-8120-c1d1390e244212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46123-006-0146123000601247 L in 1 CYLINDER (46123-006-01) 247 l1967-01-010000-00-00NoNoCurrent
46123-006-0246123000602990 L in 1 CYLINDER (46123-006-02) 990 l1967-01-010000-00-00NoNoCurrent
46123-006-03461230006031232 L in 1 CYLINDER (46123-006-03) 1232 l1967-01-010000-00-00NoNoCurrent
46123-006-04461230006041590 L in 1 CYLINDER (46123-006-04) 1590 l1967-01-010000-00-00NoNoCurrent
46123-006-05461230006052464 L in 1 CYLINDER (46123-006-05) 2464 l1967-01-010000-00-00NoNoCurrent
46123-006-06461230006063710 L in 1 CYLINDER (46123-006-06) 3710 l1967-01-010000-00-00NoNoCurrent
46123-006-07461230006074944 L in 1 CYLINDER (46123-006-07) 4944 l1967-01-010000-00-00NoNoCurrent
46123-006-08461230006087391 L in 1 CYLINDER (46123-006-08) 7391 l1967-01-010000-00-00NoNoCurrent
46123-006-09461230006097570 L in 1 CYLINDER (46123-006-09) 7570 l1967-01-010000-00-00NoNoCurrent
46123-006-104612300061013797 L in 1 CYLINDER (46123-006-10) 13797 l1967-01-010000-00-00NoNoCurrent
46123-006-114612300061116066 L in 1 CYLINDER (46123-006-11) 16066 l1967-01-010000-00-00NoNoCurrent