FDA.reportPublic FDA data

Nitrogen

Product NDC
83746-001
11-digit product format
837460001
Labeler code
83746
Product ID
83746-001_457370c3-6a94-5be5-e063-6294a90adca4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Gas and Supply Carolinas, LLC
Application
NDA205766
Marketing category
NDA
Marketing start
2023-10-16
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
83746-001-01Nitrogen388 L in 1 CYLINDERGAS3883
83746-001-02Nitrogen643 L in 1 CYLINDERGAS6433
83746-001-03Nitrogen2973 L in 1 CYLINDERGAS29733
83746-001-04Nitrogen3256 L in 1 CYLINDERGAS32563
83746-001-05Nitrogen5946 L in 1 CYLINDERGAS59463
83746-001-06Nitrogen6501 L in 1 CYLINDERGAS65013
83746-001-07Nitrogen7220 L in 1 CYLINDERGAS72203
83746-001-08Nitrogen7900 L in 1 CYLINDERGAS79003
83746-001-09Nitrogen8608 L in 1 CYLINDERGAS86083
83746-001-10Nitrogen180 L in 1 DEWARGAS1803
83746-001-11Nitrogen200 L in 1 DEWARGAS2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83746-001NITROGEN GAS [GAS AND SUPPLY CAROLINAS, LLC]2Current NDC, 11 package rows20241030_05a6f3ad-c96a-4345-e063-6294a90a8b7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347021nitrogen 99.5 % Gas for InhalationPSN05a6f3ad-c96a-4345-e063-6294a90a8b7a3
347021nitrogen 99.5 % Gas for InhalationSCD05a6f3ad-c96a-4345-e063-6294a90a8b7a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83746-001-0183746000101388 L in 1 CYLINDER (83746-001-01) 388 l2023-10-16NoNoHistorical
83746-001-0283746000102643 L in 1 CYLINDER (83746-001-02) 643 l2023-10-16NoNoHistorical
83746-001-03837460001032973 L in 1 CYLINDER (83746-001-03) 2973 l2023-10-16NoNoHistorical
83746-001-04837460001043256 L in 1 CYLINDER (83746-001-04) 3256 l2023-10-16NoNoHistorical
83746-001-05837460001055946 L in 1 CYLINDER (83746-001-05) 5946 l2023-10-16NoNoHistorical
83746-001-06837460001066501 L in 1 CYLINDER (83746-001-06) 6501 l2023-10-16NoNoHistorical
83746-001-07837460001077220 L in 1 CYLINDER (83746-001-07) 7220 l2023-10-16NoNoHistorical
83746-001-08837460001087900 L in 1 CYLINDER (83746-001-08) 7900 l2023-10-16NoNoHistorical
83746-001-09837460001098608 L in 1 CYLINDER (83746-001-09) 8608 l2023-10-16NoNoHistorical
83746-001-1083746000110180 L in 1 DEWAR (83746-001-10) 180 l2023-10-16NoNoHistorical
83746-001-1183746000111200 L in 1 DEWAR (83746-001-11) 200 l2023-10-16NoNoHistorical