FDA.reportPublic FDA data

Nitrogen

Product NDC
84078-001
11-digit product format
840780001
Labeler code
84078
Product ID
84078-001_50871b9d-735b-0673-e063-6294a90a560d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.
Application
NDA205891
Marketing category
NDA
Marketing start
2024-01-29
Substance
NITROGEN
Active strength
992 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrogen
Listing expiration
2027-12-31

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
84078-001-01Nitrogen8501 L in 1 CYLINDERGAS85017
84078-001-02Nitrogen230 L in 1 CYLINDERGAS2307
84078-001-03Nitrogen6453 L in 1 CYLINDERGAS64537
84078-001-04Nitrogen651 L in 1 CYLINDERGAS6517
84078-001-05Nitrogen1090 L in 1 CYLINDERGAS10907
84078-001-06Nitrogen5924 L in 1 CYLINDERGAS59247
84078-001-07Nitrogen7810 L in 1 CYLINDERGAS78107
84078-001-08Nitrogen104300 L in 1 CYLINDERGAS1043007
84078-001-09Nitrogen116100 L in 1 CYLINDERGAS1161007
84078-001-10Nitrogen230 L in 1 CYLINDERGAS2307
84078-001-11Nitrogen160 L in 1 CYLINDERGAS1607
84078-001-12Nitrogen180 L in 1 CYLINDERGAS1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84078-001NITROGEN GAS [WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.]2Current NDC, 12 package rows20241204_1017e562-498d-9554-e063-6394a90ab566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348624nitrogen 99.2 % Gas for InhalationPSN1017e562-498d-9554-e063-6394a90ab5667
348624nitrogen 99.2 % Gas for InhalationSCD1017e562-498d-9554-e063-6394a90ab5667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84078-001-01840780001018501 L in 1 CYLINDER8501 lHistorical
84078-001-0284078000102230 L in 1 CYLINDER230 lHistorical
84078-001-03840780001036453 L in 1 CYLINDER6453 lHistorical
84078-001-0484078000104651 L in 1 CYLINDER (84078-001-04) 651 l2024-01-29NoNoHistorical
84078-001-05840780001051090 L in 1 CYLINDER (84078-001-05) 1090 l2024-01-29NoNoHistorical
84078-001-06840780001065924 L in 1 CYLINDER (84078-001-06) 5924 l2024-01-29NoNoHistorical
84078-001-07840780001077810 L in 1 CYLINDER (84078-001-07) 7810 l2024-01-29NoNoHistorical
84078-001-0884078000108104300 L in 1 CYLINDER104300 lHistorical
84078-001-0984078000109116100 L in 1 CYLINDER116100 lHistorical
84078-001-1084078000110230 L in 1 CYLINDER (84078-001-10) 230 l2024-01-29NoNoHistorical
84078-001-1184078000111160 L in 1 CYLINDER (84078-001-11) 160 l2024-01-29NoNoHistorical
84078-001-1284078000112180 L in 1 CYLINDER (84078-001-12) 180 l2024-01-29NoNoHistorical