FDA.reportPublic FDA data

Nitrogen

Product NDC
43621-002
11-digit product format
436210002
Labeler code
43621
Product ID
43621-002_4bbd6328-0ab4-273d-e063-6294a90a43cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
DJB Gas Services, Inc
Application
NDA205713
Marketing category
NDA
Marketing start
2016-03-04
Substance
NITROGEN
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
b28d71c9-b258-4d88-81e5-c84cd4981a82Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43621-002-22Nitrogen6512 L in 1 CYLINDERGAS651220
43621-002-23Nitrogen8608 L in 1 CYLINDERGAS860820
43621-002-24Nitrogen180 L in 1 DEWARGAS18020
43621-002-25Nitrogen1613 L in 1 CYLINDERGAS161320
43621-002-26Nitrogen230 L in 1 DEWARGAS23020
43621-002-27Nitrogen265 L in 1 DEWARGAS26520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43621-002NITROGEN GAS [DJB GAS SERVICES, INC]18Current NDC, Legacy NDC, 6 package rows20250115_b28d71c9-b258-4d88-81e5-c84cd4981a82.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
ndc (product): 43621-002
NitrogenNITROGENIWS Gas and Supply of Texas, LTDbfe95982-1606-4878-95b0-5d3bc662cc2c2025-12-08Exact identifier
application applno (NDA): 205713
application number: NDA205713
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
311998nitrogen 99 % Gas for InhalationPSNb28d71c9-b258-4d88-81e5-c84cd4981a8220
311998nitrogen 99 % Gas for InhalationSCDb28d71c9-b258-4d88-81e5-c84cd4981a8220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43621-002-22436210002226512 L in 1 CYLINDER (43621-002-22) 6512 l2016-03-040000-00-00NoNoCurrent
43621-002-23436210002238608 L in 1 CYLINDER (43621-002-23) 8608 l2016-03-040000-00-00NoNoCurrent
43621-002-2443621000224180 L in 1 DEWAR (43621-002-24) 180 l2016-03-04NoNoCurrent
43621-002-25436210002251613 L in 1 CYLINDER (43621-002-25) 1613 l2016-03-04NoNoCurrent
43621-002-2643621000226230 L in 1 DEWAR (43621-002-26) 230 l2016-03-04NoNoCurrent
43621-002-2743621000227265 L in 1 DEWAR (43621-002-27) 265 l2016-03-04NoNoCurrent