FDA.reportPublic FDA data

Nitrogen

Product NDC
53440-002
11-digit product format
534400002
Labeler code
53440
Product ID
53440-002_4487ca09-1ab2-1181-e063-6394a90a4d46
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
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiN762921K75
Rxcui347021

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

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 startMarketing endSampleExclude flagStatus
53440-002-0153440000201240 L in 1 DEWAR (53440-002-01) 240 l2000-01-010000-00-00NoNoCurrent
53440-002-0253440000202230 L in 1 DEWAR (53440-002-02) 230 l2000-01-010000-00-00NoNoCurrent
53440-002-0353440000203180 L in 1 DEWAR (53440-002-03) 180 l2000-01-010000-00-00NoNoCurrent
53440-002-0453440000204160 L in 1 DEWAR (53440-002-04) 160 l2000-01-010000-00-00NoNoCurrent
53440-002-055344000020533984 L in 1 CYLINDER (53440-002-05) 33984 l2000-01-010000-00-00NoNoCurrent
53440-002-06534400002068496 L in 1 CYLINDER (53440-002-06) 8496 l2000-01-010000-00-00NoNoCurrent
53440-002-07534400002075664 L in 1 CYLINDER (53440-002-07) 5664 l2000-01-010000-00-00NoNoCurrent
53440-002-08534400002081416 L in 1 CYLINDER (53440-002-08) 1416 l2000-01-010000-00-00NoNoCurrent
53440-002-0953440000209623 L in 1 CYLINDER (53440-002-09) 623 l2000-01-010000-00-00NoNoCurrent
53440-002-105344000021010 L in 1 CYLINDER (53440-002-10) 10 l2000-01-01NoNoHistorical
53440-002-115344000021125 L in 1 CYLINDER (53440-002-11) 25 l2000-01-01NoNoHistorical
53440-002-125344000021235 L in 1 CYLINDER (53440-002-12) 35 l2000-01-01NoNoHistorical
53440-002-1353440000213176 L in 1 CYLINDER (53440-002-13) 176 l2000-01-01NoNoHistorical
53440-002-1453440000214196 L in 1 CYLINDER (53440-002-14) 196 l2000-01-01NoNoHistorical
53440-002-1553440000215230 L in 1 CYLINDER (53440-002-15) 230 l2000-01-01NoNoHistorical
53440-002-1653440000216388 L in 1 CYLINDER (53440-002-16) 388 l2000-01-01NoNoHistorical
53440-002-1753440000217643 L in 1 CYLINDER (53440-002-17) 643 l2000-01-01NoNoHistorical
53440-002-1853440000218957 L in 1 CYLINDER (53440-002-18) 957 l2000-01-01NoNoHistorical
53440-002-19534400002193030 L in 1 CYLINDER (53440-002-19) 3030 l2000-01-01NoNoHistorical
53440-002-20534400002205863 L in 1 CYLINDER (53440-002-20) 5863 l2000-01-01NoNoHistorical
53440-002-21534400002217801 L in 1 CYLINDER (53440-002-21) 7801 l2000-01-01NoNoHistorical
53440-002-225344000022235778 L in 1 CYLINDER (53440-002-22) 35778 l2000-01-01NoNoHistorical