FDA.reportPublic FDA data

NITROGEN

Product NDC
45405-002
Requested package NDC
45405-002-01
11-digit product format
454050002
Labeler code
45405
Product ID
45405-002_cd52f450-b109-4eb1-8b72-9868ee123baf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGEN
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Gas Innovations LLC
Application
NDA205866
Marketing category
NDA
Marketing start
1972-01-01
Marketing end
0000-00-00
Substance
NITROGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage45405-00245405-002-01IInactivated by FDA2026-10-12

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 · 15 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
45405-002-01NITROGEN -002
45405-002-02NITROGEN -002
45405-002-03NITROGEN -002
45405-002-04NITROGEN -002
45405-002-05NITROGEN -002
45405-002-06NITROGEN -002
45405-002-07NITROGEN -002
45405-002-08NITROGEN -002
45405-002-09NITROGEN -002
45405-002-10NITROGEN -002
45405-002-11NITROGEN -002
45405-002-12NITROGEN -002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45405-002-01NITROGEN425 L in 1 CYLINDERGAS42511
45405-002-02NITROGEN675 L in 1 CYLINDERGAS67511
45405-002-03NITROGEN3500 L in 1 CANGAS350011
45405-002-04NITROGEN6900 L in 1 CYLINDERGAS690011
45405-002-05NITROGEN7800 L in 1 CYLINDERGAS780011
45405-002-06NITROGEN150000 L in 1 DEWARGAS15000011
45405-002-07NITROGEN185000 L in 1 DEWARGAS18500011
45405-002-08NITROGEN198000 L in 1 DEWARGAS19800011
45405-002-09NITROGEN683000 L in 1 TANKGAS68300011
45405-002-10NITROGEN950000 L in 1 TANKGAS95000011
45405-002-11NITROGEN1350000 L in 1 TANKGAS135000011
45405-002-12NITROGEN1955000 L in 1 TANKGAS195500011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGENACTIVE INGREDIENTN762921K75NITROGEN GAS [GAS INNOVATIONS LLC]1
NITROGENACTIVE MOIETYN762921K75NITROGEN GAS [GAS INNOVATIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45405-002NITROGEN GAS [GAS INNOVATIONS LLC]11Legacy NDC, 12 package rows20221012_1fe76ca1-6643-458d-b012-78fd51d64433.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 InhalationPSN1fe76ca1-6643-458d-b012-78fd51d6443311
311998nitrogen 99 % Gas for InhalationSCD1fe76ca1-6643-458d-b012-78fd51d6443311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45405-002-0145405000201425 L in 1 CYLINDER (45405-002-01) 425 l1972-01-010000-00-00NoNoCurrent