FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
53440-003
11-digit product format
534400003
Labeler code
53440
Product ID
53440-003_4487d01b-70d3-2154-e063-6394a90ad85e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Westair Gases & Equipment, Inc.
Application
NDA206009
Marketing category
NDA
Marketing start
2000-01-01
Substance
NITROUS OXIDE
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53440-00353440-003-01DDiscontinued by firm2026-10-05
excluded packagepackage53440-00353440-003-02DDiscontinued by firm2026-10-05
excluded packagepackage53440-00353440-003-03DDiscontinued by firm2026-10-05
excluded packagepackage53440-00353440-003-04DDiscontinued by firm2026-10-05
excluded packagepackage53440-00353440-003-05DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0553440-003-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553440-003-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553440-003-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553440-003-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553440-003-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2653440-003-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653440-003-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653440-003-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653440-003-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653440-003-02f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrous Oxide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROUS OXIDE995 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K50XQU1029Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
347046Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec885e73-b328-4bbb-90bf-728ec9517ad7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53440-003-01Nitrous Oxide13815 L in 1 CYLINDERGAS1381515
53440-003-02Nitrous Oxide7400 L in 1 CYLINDERGAS740015
53440-003-03Nitrous Oxide4934 L in 1 CYLINDERGAS493415
53440-003-04Nitrous Oxide1653 L in 1 CYLINDERGAS165315
53440-003-05Nitrous Oxide863 L in 1 CYLINDERGAS86315
53440-003-06Nitrous Oxide711 L in 1 CYLINDERGAS71115
53440-003-07Nitrous Oxide1337 L in 1 CYLINDERGAS133715
53440-003-08Nitrous Oxide5167 L in 1 CYLINDERGAS516715
53440-003-09Nitrous Oxide14163 L in 1 CYLINDERGAS1416315

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [WESTAIR GASES & EQUIPMENT, INC.]2
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [WESTAIR GASES & EQUIPMENT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53440-003NITROUS OXIDE GAS [WESTAIR GASES & EQUIPMENT, INC.]14Current NDC, Legacy NDC, 9 package rows20250409_ec885e73-b328-4bbb-90bf-728ec9517ad7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROUS OXIDENITROUS OXIDEAir Source Industrieseebd56c1-4ab3-409b-9767-e54dc42f2fce2024-10-06Exact identifier
application applno (NDA): 206009
application number: NDA206009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347046nitrous oxide 99.5 % Gas for InhalationPSNec885e73-b328-4bbb-90bf-728ec9517ad715
347046nitrous oxide 99.5 % Gas for InhalationSCDec885e73-b328-4bbb-90bf-728ec9517ad715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53440-003-015344000030113815 L in 1 CYLINDER (53440-003-01) 13815 l2000-01-010000-00-00NoNoCurrent
53440-003-02534400003027400 L in 1 CYLINDER (53440-003-02) 7400 l2000-01-010000-00-00NoNoCurrent
53440-003-03534400003034934 L in 1 CYLINDER (53440-003-03) 4934 l2000-01-010000-00-00NoNoCurrent
53440-003-04534400003041653 L in 1 CYLINDER (53440-003-04) 1653 l2000-01-010000-00-00NoNoCurrent
53440-003-0553440000305863 L in 1 CYLINDER (53440-003-05) 863 l2000-01-010000-00-00NoNoCurrent
53440-003-0653440000306711 L in 1 CYLINDER (53440-003-06) 711 l2000-01-01NoNoCurrent
53440-003-07534400003071337 L in 1 CYLINDER (53440-003-07) 1337 l2000-01-01NoNoCurrent
53440-003-08534400003085167 L in 1 CYLINDER (53440-003-08) 5167 l2000-01-01NoNoCurrent
53440-003-095344000030914163 L in 1 CYLINDER (53440-003-09) 14163 l2000-01-01NoNoCurrent