Nitrous Oxide

Product NDC
34057-010
Requested package NDC
34057-010-04
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage34057-01034057-010-04DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage34057-01034057-010-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage34057-01034057-010-04DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

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 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
312022Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56d37fcb-8abf-4671-9388-a8837c94e5a2Available on FDA.report

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

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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nitrous OxideNITROUS OXIDENEXAIR, LLCa6f744e1-d94d-49e1-ab9f-9a88f04f54992026-05-21Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDERed Ball Oxygen Co., Inc.02a3cf7f-d0a5-4edd-bc84-d9162558434b2026-02-06Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEAGL Welding Supply Co., Inc.75c1da96-5cc4-4826-bbd0-dc6a9142b51c2026-01-01Exact identifier
application applno (NDA): 206009
application number: NDA206009
NITROUS OXIDENITROUS OXIDENorco, Inca5403bef-c22d-4246-be7a-a198aa2540012025-12-15Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEQuality Air Products Inc044d220f-99fc-49ba-b4ad-18ff54d805f12025-12-09Exact identifier
application applno (NDA): 206009
application number: NDA206009
NITROUS OXIDENITROUS OXIDESpectrum Gas Products, Incb550ebb2-e617-4913-8f75-1a07662e87e52025-12-03Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEWestair Gases & Equipment, Inc.ec885e73-b328-4bbb-90bf-728ec9517ad72025-11-26Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEOxarc, LLC56d37fcb-8abf-4671-9388-a8837c94e5a22025-11-25Exact identifier
application applno (NDA): 206009
application number: NDA206009
ndc (package): 34057-010-04
ndc (product): 34057-010
ndc11 (package): 34057001004
Nitrous OxideNITROUS OXIDEFULLERTON WELDING SUPPLY25dd7dca-2cfd-1e1c-e063-6294a90ad2382025-11-21Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDERoberts Oxygen Company, Inc.988190eb-1449-482c-8120-c1d1390e24422025-11-17Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDERoberts Oxygen Company, Inc.aaa2ed08-c5cb-4d46-917b-ce1a9d0ce4622025-11-17Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous Oxide Oxygen MixNITROUS OXIDE OXYGEN MIXRoberts Oxygen Company, Inc.43cfee1f-c7e1-6db4-e063-6294a90a5b4d2025-11-17Exact identifier
application applno (NDA): 206009
application number: NDA206009
NITROUS OXIDENITROUS OXIDEKeen Compressed Gas Co. Inc.cdefd579-5acb-45e0-a743-61426a7d26152025-11-17Exact identifier
application applno (NDA): 206009
application number: NDA206009
NITROUS OXIDENITROUS OXIDEHolston Gases, Inc3ffb8392-963f-4b3a-b0eb-8791ea6309ff2025-11-14Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDENitrous Oxide2b0b9cc4-fca7-4e84-8d9d-0f98525285792025-11-11Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDENitrous Oxide of Canada6cd11814-c704-1b74-e053-2991aa0a06192025-11-11Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEAGP LLC25c59b03-863d-f108-e063-6294a90ac4542025-11-04Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEILMO Products Companybc5b4097-9292-41a2-82bb-30671b9ecf422025-10-29Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEAero All Gas Companybd405eab-ac43-4590-975d-d0d1e8f788332025-10-28Exact identifier
application applno (NDA): 206009
application number: NDA206009
Nitrous OxideNITROUS OXIDEDuPuy Oxygen & Supply Company, Inc.9eae094f-564c-4e69-aa96-d33fd375f5e82025-10-24Exact identifier
application applno (NDA): 206009
application number: NDA206009

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
34057-010-043405700100412063 L in 1 CYLINDER (34057-010-04) 12063 l1977-01-010000-00-00NoNoCurrent