FDA.reportPublic FDA data

Nitrogen

Product NDC
33335-002
11-digit product format
333350002
Labeler code
33335
Product ID
33335-002_eb4114b3-8d10-4a90-e053-2a95a90a95fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WELSCO, INC.
Application
NDA205766
Marketing category
NDA
Marketing start
2001-01-01
Marketing end
0000-00-00
Substance
NITROGEN
Active strength
990 mL/L
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33335-002DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-01DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-02DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-03DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-04DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-05DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-06DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-07DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-08DDiscontinued by firm2026-10-05
excluded packagepackage33335-00233335-002-09DDiscontinued by firm2026-10-05

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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NitrogenACTIVE INGREDIENTN762921K75NITROGEN GAS [WELSCO, INC.]3
NitrogenACTIVE MOIETYN762921K75NITROGEN GAS [WELSCO, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33335-002NITROGEN GAS [WELSCO, INC.]16Legacy NDC20241204_713aaf2d-05bb-401d-977b-31542720a55a.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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENADF Welding & Medical, Inc.174cb8ea-66fb-4d0b-920f-01fba9537ee92024-10-02Exact identifier
application applno (NDA): 205766
application number: NDA205766

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33335-002-01333350002016513 L in 1 CYLINDER (33335-002-01) 6513 l2001-01-010000-00-00NoNoCurrent
33335-002-02333350002023256 L in 1 CYLINDER (33335-002-02) 3256 l2001-01-010000-00-00NoNoCurrent
33335-002-03333350002031104 L in 1 CYLINDER (33335-002-03) 1104 l2001-01-010000-00-00NoNoCurrent
33335-002-0433335000204114740 L in 1 CYLINDER (33335-002-04) 114740 l2001-01-010000-00-00NoNoCurrent
33335-002-0533335000205104716 L in 1 CYLINDER (33335-002-05) 104716 l2001-01-010000-00-00NoNoCurrent
33335-002-063333500020630 L in 1 CYLINDER (33335-002-06) 30 l2001-01-010000-00-00NoNoCurrent
33335-002-073333500020725 L in 1 CYLINDER (33335-002-07) 25 l2001-01-010000-00-00NoNoCurrent
33335-002-083333500020820 L in 1 CYLINDER (33335-002-08) 20 l2001-01-010000-00-00NoNoCurrent
33335-002-093333500020926497 L in 1 TANK (33335-002-09) 26497 l2001-01-010000-00-00NoNoCurrent