FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
12213-593
11-digit product format
122130593
Labeler code
12213
Product ID
12213-593_52588e75-ec07-e529-e063-6294a90a1af8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
NEXAIR, LLC
Application
NDA206009
Marketing category
NDA
Marketing start
1996-06-01
Substance
NITROUS OXIDE
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage12213-59312213-593-11DDiscontinued by firm2026-08-17
excluded packagepackage12213-59312213-593-12DDiscontinued 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 · 24 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 2025-12-0512213-593-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0512213-593-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2612213-593-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2612213-593-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3112213-593-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3112213-593-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2812213-593-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2812213-593-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2112213-593-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2112213-593-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1012213-593-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1012213-593-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3112213-593-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3112213-593-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2012213-593-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2012213-593-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1012213-593-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1012213-593-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0812213-593-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0812213-593-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0312213-593-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0312213-593-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0912213-593-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0912213-593-12557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

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

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
a6f744e1-d94d-49e1-ab9f-9a88f04f5499Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-593-11Nitrous Oxide4928 L in 1 CYLINDERGAS492820
12213-593-12Nitrous Oxide13798 L in 1 CYLINDERGAS1379820
12213-593-13Nitrous Oxide986 L in 1 CYLINDERGAS98620
12213-593-14Nitrous Oxide1628 L in 1 CYLINDERGAS162820
12213-593-15Nitrous Oxide2468 L in 1 CYLINDERGAS246820
12213-593-16Nitrous Oxide14328 L in 1 CYLINDERGAS1432820
12213-593-17Nitrous Oxide13818 L in 1 CYLINDERGAS1381820
12213-593-18Nitrous Oxide4936 L in 1 CYLINDERGAS493620
12213-593-19Nitrous Oxide15818.5 L in 1 CYLINDERGAS15818.520
12213-593-20Nitrous Oxide17798 L in 1 CYLINDERGAS1779820
12213-593-21Nitrous Oxide4063 L in 1 CYLINDERGAS406320
12213-593-22Nitrous Oxide170 L in 1 CYLINDERGAS17020
12213-593-23Nitrous Oxide408 L in 1 CYLINDERGAS40820
12213-593-24Nitrous Oxide180 L in 1 DEWARGAS18020
12213-593-25Nitrous Oxide113 L in 1 CYLINDERGAS11320
12213-593-28Nitrous Oxide99647 L in 1 CYLINDERGAS9964720
12213-593-37Nitrous Oxide7885 L in 1 CYLINDERGAS788520
12213-593-58Nitrous Oxide1577 L in 1 CYLINDERGAS157720

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [NEXAIR, LLC]2
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [NEXAIR, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12213-593NITROUS OXIDE GAS [NEXAIR, LLC]18Current NDC, Legacy NDC, 18 package rows20241114_a6f744e1-d94d-49e1-ab9f-9a88f04f5499.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
ndc (product): 12213-593
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
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 InhalationPSNa6f744e1-d94d-49e1-ab9f-9a88f04f549920
312022nitrous oxide 99 % Gas for InhalationSCDa6f744e1-d94d-49e1-ab9f-9a88f04f549920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12213-593-11122130593114928 L in 1 CYLINDER (12213-593-11) 4928 l1996-06-010000-00-00NoNoCurrent
12213-593-121221305931213798 L in 1 CYLINDER (12213-593-12) 13798 l1996-06-010000-00-00NoNoCurrent
12213-593-1312213059313986 L in 1 CYLINDER (12213-593-13) 986 l1996-06-010000-00-00NoNoCurrent
12213-593-14122130593141628 L in 1 CYLINDER (12213-593-14) 1628 l1996-06-010000-00-00NoNoCurrent
12213-593-15122130593152468 L in 1 CYLINDER (12213-593-15) 2468 l1996-06-010000-00-00NoNoCurrent
12213-593-161221305931614328 L in 1 CYLINDER (12213-593-16) 14328 l1996-06-010000-00-00NoNoCurrent
12213-593-171221305931713818 L in 1 CYLINDER (12213-593-17) 13818 l1996-06-010000-00-00NoNoCurrent
12213-593-18122130593184936 L in 1 CYLINDER (12213-593-18) 4936 l1996-06-010000-00-00NoNoCurrent
12213-593-191221305931915818.5 L in 1 CYLINDER (12213-593-19) 15818.5 l1996-06-010000-00-00NoNoCurrent
12213-593-201221305932017798 L in 1 CYLINDER (12213-593-20) 17798 l1996-06-010000-00-00NoNoCurrent
12213-593-21122130593214063 L in 1 CYLINDER (12213-593-21) 4063 l1996-06-010000-00-00NoNoCurrent
12213-593-2212213059322170 L in 1 CYLINDER (12213-593-22) 170 l1996-06-010000-00-00NoNoCurrent
12213-593-2312213059323408 L in 1 CYLINDER (12213-593-23) 408 l1996-06-010000-00-00NoNoCurrent
12213-593-2412213059324180 L in 1 DEWAR (12213-593-24) 180 l1996-06-010000-00-00NoNoCurrent
12213-593-2512213059325113 L in 1 CYLINDER (12213-593-25) 113 l1996-06-010000-00-00NoNoCurrent
12213-593-281221305932899647 L in 1 CYLINDER (12213-593-28) 99647 l1996-06-010000-00-00NoNoCurrent
12213-593-37122130593377885 L in 1 CYLINDER (12213-593-37) 7885 l1996-06-010000-00-00NoNoCurrent
12213-593-58122130593581577 L in 1 CYLINDER (12213-593-58) 1577 l1996-06-010000-00-00NoNoCurrent