FDA.reportPublic FDA data

Nitrogen

Product NDC
50063-002
11-digit product format
500630002
Labeler code
50063
Product ID
50063-002_426517f1-9576-8ca6-e063-6394a90a74ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Andy-Oxy Co., Inc.
Application
NDA205766
Marketing category
NDA
Marketing start
2013-01-01
Substance
NITROGEN
Active strength
992 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
NITROGEN992 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN762921K75
Rxcui348624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50063-002-01Nitrogen623 L in 1 CYLINDERGAS62320
50063-002-02Nitrogen6513 L in 1 CYLINDERGAS651320
50063-002-03Nitrogen2322 L in 1 CYLINDERGAS232220
50063-002-04Nitrogen3200 L in 1 CYLINDERGAS320020
50063-002-05Nitrogen8495 L in 1 CYLINDERGAS849520
50063-002-06Nitrogen11440 L in 1 DEWARGAS1144020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGENACTIVE INGREDIENTN762921K75NITROGEN GAS [ANDY-OXY CO., INC.]8
NITROGENACTIVE MOIETYN762921K75NITROGEN GAS [ANDY-OXY CO., INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50063-002NITROGEN GAS [ANDY-OXY CO., INC.]19Current NDC, Legacy NDC, 6 package rows20241012_2914edb9-b3e3-4407-8be3-3e830f710e74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348624nitrogen 99.2 % Gas for InhalationPSN2914edb9-b3e3-4407-8be3-3e830f710e7420
348624nitrogen 99.2 % Gas for InhalationSCD2914edb9-b3e3-4407-8be3-3e830f710e7420

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50063-002-0150063000201623 L in 1 CYLINDER (50063-002-01) 623 l2013-01-010000-00-00NoNoCurrent
50063-002-02500630002026513 L in 1 CYLINDER (50063-002-02) 6513 l2013-01-010000-00-00NoNoCurrent
50063-002-03500630002032322 L in 1 CYLINDER (50063-002-03) 2322 l2013-01-010000-00-00NoNoCurrent
50063-002-04500630002043200 L in 1 CYLINDER (50063-002-04) 3200 l2013-01-010000-00-00NoNoCurrent
50063-002-05500630002058495 L in 1 CYLINDER (50063-002-05) 8495 l2013-01-010000-00-00NoNoCurrent
50063-002-065006300020611440 L in 1 DEWAR (50063-002-06) 11440 l2013-01-010000-00-00NoNoCurrent