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

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGEN992 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
348624Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2914edb9-b3e3-4407-8be3-3e830f710e74Available on FDA.report

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

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
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