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

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
NITROGEN995 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
347021Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05a6f3ad-c96a-4345-e063-6294a90a8b7aAvailable on FDA.report

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

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
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 l2023-10-16NoNoCurrent
83746-001-0283746000102643 L in 1 CYLINDER (83746-001-02) 643 l2023-10-16NoNoCurrent
83746-001-03837460001032973 L in 1 CYLINDER (83746-001-03) 2973 l2023-10-16NoNoCurrent
83746-001-04837460001043256 L in 1 CYLINDER (83746-001-04) 3256 l2023-10-16NoNoCurrent
83746-001-05837460001055946 L in 1 CYLINDER (83746-001-05) 5946 l2023-10-16NoNoCurrent
83746-001-06837460001066501 L in 1 CYLINDER (83746-001-06) 6501 l2023-10-16NoNoCurrent
83746-001-07837460001077220 L in 1 CYLINDER (83746-001-07) 7220 l2023-10-16NoNoCurrent
83746-001-08837460001087900 L in 1 CYLINDER (83746-001-08) 7900 l2023-10-16NoNoCurrent
83746-001-09837460001098608 L in 1 CYLINDER (83746-001-09) 8608 l2023-10-16NoNoCurrent
83746-001-1083746000110180 L in 1 DEWAR (83746-001-10) 180 l2023-10-16NoNoCurrent
83746-001-1183746000111200 L in 1 DEWAR (83746-001-11) 200 l2023-10-16NoNoCurrent