FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
34057-010
11-digit product format
340570010
Labeler code
34057
Product ID
34057-010_4475d50c-af27-b545-e063-6294a90a6b20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Oxarc, LLC
Application
NDA206009
Marketing category
NDA
Marketing start
1977-01-01
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
34057-010-01Nitrous Oxide906 L in 1 CYLINDERGAS90617
34057-010-02Nitrous Oxide1557 L in 1 CYLINDERGAS155717
34057-010-03Nitrous Oxide4814 L in 1 CYLINDERGAS481417
34057-010-04Nitrous Oxide12063 L in 1 CYLINDERGAS1206317
34057-010-05Nitrous Oxide15461 L in 1 CYLINDERGAS1546117
34057-010-06Nitrous Oxide18123 L in 1 CYLINDERGAS1812317

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [OXARC, INC.]4
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [OXARC, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34057-010NITROUS OXIDE GAS [OXARC, LLC]16Current NDC, Legacy NDC, 6 package rows20250331_56d37fcb-8abf-4671-9388-a8837c94e5a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312022nitrous oxide 99 % Gas for InhalationPSN56d37fcb-8abf-4671-9388-a8837c94e5a217
312022nitrous oxide 99 % Gas for InhalationSCD56d37fcb-8abf-4671-9388-a8837c94e5a217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34057-010-0134057001001906 L in 1 CYLINDER (34057-010-01) 906 l1977-01-010000-00-00NoNoCurrent
34057-010-02340570010021557 L in 1 CYLINDER (34057-010-02) 1557 l1977-01-010000-00-00NoNoCurrent
34057-010-03340570010034814 L in 1 CYLINDER (34057-010-03) 4814 l1977-01-010000-00-00NoNoCurrent
34057-010-043405700100412063 L in 1 CYLINDER (34057-010-04) 12063 l1977-01-010000-00-00NoNoCurrent
34057-010-053405700100515461 L in 1 CYLINDER (34057-010-05) 15461 l1977-01-010000-00-00NoNoCurrent
34057-010-063405700100618123 L in 1 CYLINDER (34057-010-06) 18123 l1977-01-010000-00-00NoNoCurrent