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

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
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

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