Nitrogen

Product NDC
23647-002
11-digit product format
236470002
Labeler code
23647
Product ID
23647-002_45c700db-8d21-cf27-e063-6394a90a8c4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
SYOXSA, Inc.
Application
NDA205829
Marketing category
NDA
Marketing start
2011-10-30
Substance
NITROGEN
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage23647-00223647-002-01DDiscontinued by firm2026-08-03
excluded packagepackage23647-00223647-002-02DDiscontinued by firm2026-08-03
excluded packagepackage23647-00223647-002-03DDiscontinued by firm2026-08-03

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 · 21 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 2025-12-0523647-002-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0523647-002-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0523647-002-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2623647-002-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2623647-002-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2623647-002-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3123647-002-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3123647-002-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3123647-002-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2823647-002-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2823647-002-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2823647-002-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2123647-002-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2123647-002-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2123647-002-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1023647-002-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1023647-002-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1023647-002-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3123647-002-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3123647-002-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3123647-002-03302b2466d912…e7b80fea0513…

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGEN990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N762921K75Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311998Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
66b47ed5-82d0-44ba-a2aa-17db9b98ee22Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23647-002-01Nitrogen8608 L in 1 CYLINDERGAS860813
23647-002-02Nitrogen6512 L in 1 CYLINDERGAS651213
23647-002-03Nitrogen2265 L in 1 CYLINDERGAS226513
23647-002-04Nitrogen8501 L in 1 CYLINDERGAS850113
23647-002-05Nitrogen6453 L in 1 CYLINDERGAS645313
23647-002-06Nitrogen2240 L in 1 CYLINDERGAS224013
23647-002-07Nitrogen1052 L in 1 CYLINDERGAS105213

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGENACTIVE INGREDIENTN762921K75NITROGEN GAS [SYOXSA, INC.]1
NITROGENACTIVE MOIETYN762921K75NITROGEN GAS [SYOXSA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23647-002NITROGEN GAS [SYOXSA, INC.]12Current NDC, Legacy NDC, 7 package rows20250124_66b47ed5-82d0-44ba-a2aa-17db9b98ee22.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENSYOXSA, Inc.66b47ed5-82d0-44ba-a2aa-17db9b98ee222025-12-12Exact identifier
application applno (NDA): 205829
application number: NDA205829
ndc (product): 23647-002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311998nitrogen 99 % Gas for InhalationPSN66b47ed5-82d0-44ba-a2aa-17db9b98ee2213
311998nitrogen 99 % Gas for InhalationSCD66b47ed5-82d0-44ba-a2aa-17db9b98ee2213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23647-002-01236470002018608 L in 1 CYLINDER (23647-002-01) 8608 l2011-10-300000-00-00NoNoCurrent
23647-002-02236470002026512 L in 1 CYLINDER (23647-002-02) 6512 l2011-10-300000-00-00NoNoCurrent
23647-002-03236470002032265 L in 1 CYLINDER (23647-002-03) 2265 l2011-10-300000-00-00NoNoCurrent
23647-002-04236470002048501 L in 1 CYLINDER (23647-002-04) 8501 l2011-10-30NoNoCurrent
23647-002-05236470002056453 L in 1 CYLINDER (23647-002-05) 6453 l2011-10-30NoNoCurrent
23647-002-06236470002062240 L in 1 CYLINDER (23647-002-06) 2240 l2011-10-30NoNoCurrent
23647-002-07236470002071052 L in 1 CYLINDER (23647-002-07) 1052 l2011-10-30NoNoCurrent