FDA.reportPublic FDA data

Nitrogen

Product NDC
50322-003
Requested package NDC
50322-003-09
11-digit product format
503220003
Labeler code
50322
Product ID
50322-003_5e353082-03e7-e270-e063-6394a90a2a79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
C & C Oxygen Company
Application
NDA205866
Marketing category
NDA
Marketing start
2009-01-01
Substance
NITROGEN
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50322-00350322-003-09DDiscontinued by firm2026-10-20

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
Nitrogen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGEN990 mL/L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50322-003-01Nitrogen230 L in 1 DEWARGAS23023
50322-003-02Nitrogen20 L in 1 DEWARGAS2023
50322-003-03Nitrogen30 L in 1 DEWARGAS3023
50322-003-04Nitrogen40 L in 1 DEWARGAS4023
50322-003-05Nitrogen50 L in 1 DEWARGAS5023
50322-003-06Nitrogen160 L in 1 DEWARGAS16023
50322-003-07Nitrogen180 L in 1 DEWARGAS18023
50322-003-08Nitrogen623 L in 1 CYLINDERGAS62323
50322-003-09Nitrogen6512 L in 1 CYLINDERGAS651223
50322-003-10Nitrogen3256 L in 1 CYLINDERGAS325623
50322-003-11Nitrogen8608 L in 1 CYLINDERGAS860823
50322-003-12Nitrogen643 L in 1 CYLINDERGAS64323
50322-003-13Nitrogen6501 L in 1 CYLINDERGAS650123

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGENACTIVE INGREDIENTN762921K75NITROGEN GAS [C & C OXYGEN COMPANY]12
NITROGENACTIVE MOIETYN762921K75NITROGEN GAS [C & C OXYGEN COMPANY]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50322-003NITROGEN GAS [C & C OXYGEN COMPANY]22Current NDC, Legacy NDC, 13 package rows20241219_32d9050e-dc65-48b9-bfee-b914d3848127.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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENAir Source Industries Inc830d7d78-afa8-49bc-8c00-4d66eb72b83c2024-10-06Exact identifier
application applno (NDA): 205866
application number: NDA205866
NitrogenNITROGENAir Products and Chemicals, Inc.e4c5b56e-4c06-4980-8669-6df35e240bf92018-12-14Exact identifier
application applno (NDA): 205866
application number: NDA205866

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311998nitrogen 99 % Gas for InhalationPSN32d9050e-dc65-48b9-bfee-b914d384812723
311998nitrogen 99 % Gas for InhalationSCD32d9050e-dc65-48b9-bfee-b914d384812723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50322-003-09503220003096512 L in 1 CYLINDER (50322-003-09) 6512 l2009-01-010000-00-00NoNoCurrent