FDA.reportPublic FDA data

Nitrogen

Product NDC
53440-002
Requested package NDC
53440-002-22
11-digit product format
534400002
Labeler code
53440
Product ID
53440-002_5dd29ffc-85cb-6c5d-e063-6294a90a4cb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Westair Gases & Equipment, Inc.
Application
NDA205766
Marketing category
NDA
Marketing start
2000-01-01
Substance
NITROGEN
Active strength
995 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
NITROGEN995 mL/L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53440-002-01Nitrogen240 L in 1 DEWARGAS24017
53440-002-02Nitrogen230 L in 1 DEWARGAS23017
53440-002-03Nitrogen180 L in 1 DEWARGAS18017
53440-002-04Nitrogen160 L in 1 DEWARGAS16017
53440-002-05Nitrogen33984 L in 1 CYLINDERGAS3398417
53440-002-06Nitrogen8496 L in 1 CYLINDERGAS849617
53440-002-07Nitrogen5664 L in 1 CYLINDERGAS566417
53440-002-08Nitrogen1416 L in 1 CYLINDERGAS141617
53440-002-09Nitrogen623 L in 1 CYLINDERGAS62317
53440-002-10Nitrogen10 L in 1 CYLINDERGAS1017
53440-002-11Nitrogen25 L in 1 CYLINDERGAS2517
53440-002-12Nitrogen35 L in 1 CYLINDERGAS3517
53440-002-13Nitrogen176 L in 1 CYLINDERGAS17617
53440-002-14Nitrogen196 L in 1 CYLINDERGAS19617
53440-002-15Nitrogen230 L in 1 CYLINDERGAS23017
53440-002-16Nitrogen388 L in 1 CYLINDERGAS38817
53440-002-17Nitrogen643 L in 1 CYLINDERGAS64317
53440-002-18Nitrogen957 L in 1 CYLINDERGAS95717
53440-002-19Nitrogen3030 L in 1 CYLINDERGAS303017
53440-002-20Nitrogen5863 L in 1 CYLINDERGAS586317
53440-002-21Nitrogen7801 L in 1 CYLINDERGAS780117
53440-002-22Nitrogen35778 L in 1 CYLINDERGAS3577817

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NitrogenACTIVE INGREDIENTN762921K75NITROGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]4
NitrogenACTIVE MOIETYN762921K75NITROGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53440-002NITROGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]16Current NDC, Legacy NDC, 22 package rows20250409_0268620b-4e8b-4b62-a768-688b477e0171.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347021nitrogen 99.5 % Gas for InhalationPSN0268620b-4e8b-4b62-a768-688b477e017117
347021nitrogen 99.5 % Gas for InhalationSCD0268620b-4e8b-4b62-a768-688b477e017117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53440-002-225344000022235778 L in 1 CYLINDER (53440-002-22) 35778 l2000-01-01NoNoCurrent