FDA.reportPublic FDA data

Nitrogen

Product NDC
53425-002
11-digit product format
534250002
Labeler code
53425
Product ID
53425-002_4573f404-a9b1-390c-e063-6394a90a4221
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
IWS Gas and Supply of Texas, LTD
Application
NDA205713
Marketing category
NDA
Marketing start
2011-11-01
Substance
NITROGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGEN995 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
347021Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bfe95982-1606-4878-95b0-5d3bc662cc2cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53425-002-01Nitrogen396 L in 1 CYLINDERGAS39613
53425-002-02Nitrogen651 L in 1 CYLINDERGAS65113
53425-002-03Nitrogen2973 L in 1 CYLINDERGAS297313
53425-002-04Nitrogen5947 L in 1 CYLINDERGAS594713
53425-002-05Nitrogen6513 L in 1 CYLINDERGAS651313
53425-002-06Nitrogen6626 L in 1 CYLINDERGAS662613
53425-002-07Nitrogen7221 L in 1 CYLINDERGAS722113
53425-002-08Nitrogen7900 L in 1 CYLINDERGAS790013
53425-002-09Nitrogen8608 L in 1 CYLINDERGAS860813
53425-002-10Nitrogen180 L in 1 DEWARGAS18013
53425-002-11Nitrogen200 L in 1 DEWARGAS20013
53425-002-12Nitrogen3256 L in 1 CYLINDERGAS325613

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NitrogenACTIVE INGREDIENTN762921K75NITROGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]2
NitrogenACTIVE MOIETYN762921K75NITROGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53425-002NITROGEN GAS [IWS GAS AND SUPPLY OF TEXAS, LTD]12Current NDC, Legacy NDC, 12 package rows20241030_bfe95982-1606-4878-95b0-5d3bc662cc2c.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitrogenNITROGENArcet Equipment Company dba Arc3 Gases Northff2ba9fb-e58a-4e57-8e96-b7e90cc6e2a82026-06-18Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENDJB Gas Services, Incb28d71c9-b258-4d88-81e5-c84cd4981a822026-02-26Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENIWS Gas and Supply of Texas, LTDbfe95982-1606-4878-95b0-5d3bc662cc2c2025-12-08Exact identifier
application applno (NDA): 205713
application number: NDA205713
ndc (product): 53425-002
NitrogenNITROGENGas and Supply58dddf10-09e2-4ae6-883d-c5a9ed83d3a72025-12-03Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENSuper Gas, Inc.80a178d8-7173-4e7a-ace9-7fe3fd0e07242025-11-26Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENHARTMAN BROTHERS, INC.123ca615-78ce-4bc8-bcae-168c4740c2302025-10-24Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENWesco Gas & Welding Supply, Inc.ea2a3b5d-f53f-49cd-9e43-708f69879cce2025-10-13Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENB & J Welding Supply, LTD. dba B & J Welding Supply4faa22a2-442c-4b2a-badc-c4e502493d082025-10-09Exact identifier
application applno (NDA): 205713
application number: NDA205713
NitrogenNITROGENGIBBS WELDING SUPPLY, INC.227ee46a-2050-4e11-bfa9-6b1cc16343022025-10-08Exact identifier
application applno (NDA): 205713
application number: NDA205713

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347021nitrogen 99.5 % Gas for InhalationPSNbfe95982-1606-4878-95b0-5d3bc662cc2c13
347021nitrogen 99.5 % Gas for InhalationSCDbfe95982-1606-4878-95b0-5d3bc662cc2c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53425-002-0153425000201396 L in 1 CYLINDER (53425-002-01) 396 l2011-11-010000-00-00NoNoCurrent
53425-002-0253425000202651 L in 1 CYLINDER (53425-002-02) 651 l2011-11-010000-00-00NoNoCurrent
53425-002-03534250002032973 L in 1 CYLINDER (53425-002-03) 2973 l2011-11-010000-00-00NoNoCurrent
53425-002-04534250002045947 L in 1 CYLINDER (53425-002-04) 5947 l2011-11-010000-00-00NoNoCurrent
53425-002-05534250002056513 L in 1 CYLINDER (53425-002-05) 6513 l2011-11-010000-00-00NoNoCurrent
53425-002-06534250002066626 L in 1 CYLINDER (53425-002-06) 6626 l2011-11-010000-00-00NoNoCurrent
53425-002-07534250002077221 L in 1 CYLINDER (53425-002-07) 7221 l2011-11-010000-00-00NoNoCurrent
53425-002-08534250002087900 L in 1 CYLINDER (53425-002-08) 7900 l2011-11-010000-00-00NoNoCurrent
53425-002-09534250002098608 L in 1 CYLINDER (53425-002-09) 8608 l2011-11-010000-00-00NoNoCurrent
53425-002-1053425000210180 L in 1 DEWAR (53425-002-10) 180 l2011-11-010000-00-00NoNoCurrent
53425-002-1153425000211200 L in 1 DEWAR (53425-002-11) 200 l2011-11-010000-00-00NoNoCurrent
53425-002-12534250002123256 L in 1 CYLINDER (53425-002-12) 3256 l2011-11-010000-00-00NoNoCurrent