FDA.reportPublic FDA data

Nitrogen

Product NDC
11043-002
11-digit product format
110430002
Labeler code
11043
Product ID
11043-002_44769140-58a0-9bb4-e063-6394a90af899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
S. J. Smith Co., Inc.
Application
NDA205766
Marketing category
NDA
Marketing start
1986-01-01
Substance
NITROGEN
Active strength
990 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
NITROGEN990 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
311998Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d85670e1-a5e8-466d-bf58-9d6c75b2a691Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11043-002-01Nitrogen101579 L in 1 DEWARGAS10157917
11043-002-02Nitrogen8467 L in 1 CYLINDERGAS846717
11043-002-03Nitrogen6456 L in 1 CYLINDERGAS645617
11043-002-04Nitrogen4247 L in 1 CYLINDERGAS424717
11043-002-05Nitrogen3256 L in 1 CYLINDERGAS325617
11043-002-06Nitrogen597 L in 1 CYLINDERGAS59717
11043-002-07Nitrogen361 L in 1 CYLINDERGAS36117
11043-002-08Nitrogen5 L in 1 DEWARGAS517
11043-002-09Nitrogen10 L in 1 DEWARGAS1017
11043-002-10Nitrogen20 L in 1 DEWARGAS2017
11043-002-11Nitrogen30 L in 1 DEWARGAS3017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGENACTIVE INGREDIENTN762921K75NITROGEN GAS [S. J. SMITH CO., INC.]3
NITROGENACTIVE MOIETYN762921K75NITROGEN GAS [S. J. SMITH CO., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11043-002NITROGEN GAS [S. J. SMITH CO., INC.]15Current NDC, Legacy NDC, 11 package rows20241012_d85670e1-a5e8-466d-bf58-9d6c75b2a691.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
311998nitrogen 99 % Gas for InhalationPSNd85670e1-a5e8-466d-bf58-9d6c75b2a69117
311998nitrogen 99 % Gas for InhalationSCDd85670e1-a5e8-466d-bf58-9d6c75b2a69117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11043-002-0111043000201101579 L in 1 DEWAR (11043-002-01) 101579 l1986-01-010000-00-00NoNoCurrent
11043-002-02110430002028467 L in 1 CYLINDER (11043-002-02) 8467 l1986-01-010000-00-00NoNoCurrent
11043-002-03110430002036456 L in 1 CYLINDER (11043-002-03) 6456 l1986-01-010000-00-00NoNoCurrent
11043-002-04110430002044247 L in 1 CYLINDER (11043-002-04) 4247 l1986-01-010000-00-00NoNoCurrent
11043-002-05110430002053256 L in 1 CYLINDER (11043-002-05) 3256 l1986-01-010000-00-00NoNoCurrent
11043-002-0611043000206597 L in 1 CYLINDER (11043-002-06) 597 l1986-01-010000-00-00NoNoCurrent
11043-002-0711043000207361 L in 1 CYLINDER (11043-002-07) 361 l1986-01-010000-00-00NoNoCurrent
11043-002-08110430002085 L in 1 DEWAR (11043-002-08) 5 l1986-01-01NoNoCurrent
11043-002-091104300020910 L in 1 DEWAR (11043-002-09) 10 l1986-01-01NoNoCurrent
11043-002-101104300021020 L in 1 DEWAR (11043-002-10) 20 l1986-01-01NoNoCurrent
11043-002-111104300021130 L in 1 DEWAR (11043-002-11) 30 l1986-01-01NoNoCurrent