FDA.reportPublic FDA data

Nitrogen

Product NDC
10304-601
11-digit product format
103040601
Labeler code
10304
Product ID
10304-601_43d0dedc-523b-fec5-e063-6294a90af2c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Delille Oxygen Company
Application
NDA205866
Marketing category
NDA
Marketing start
2000-06-12
Substance
NITROGEN
Active strength
999 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
NITROGEN999 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
348987Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b82f163b-c913-431d-88cf-8b6e08d1b42aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10304-601-01Nitrogen116495 L in 1 DEWARGAS11649514
10304-601-02Nitrogen114739 L in 1 DEWARGAS11473914
10304-601-03Nitrogen6512 L in 1 CYLINDERGAS651214

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NitrogenACTIVE INGREDIENTN762921K75NITROGEN GAS [DELILLE OXYGEN COMPANY]2
NitrogenACTIVE MOIETYN762921K75NITROGEN GAS [DELILLE OXYGEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10304-601NITROGEN GAS [DELILLE OXYGEN COMPANY]13Current NDC, Legacy NDC, 3 package rows20241023_b82f163b-c913-431d-88cf-8b6e08d1b42a.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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENAir Source Industries Inc830d7d78-afa8-49bc-8c00-4d66eb72b83c2024-10-06Exact identifier
application applno (NDA): 205866
application number: NDA205866
NitrogenNITROGENAir Products and Chemicals, Inc.e4c5b56e-4c06-4980-8669-6df35e240bf92018-12-14Exact identifier
application applno (NDA): 205866
application number: NDA205866

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348987nitrogen 99.9 % Gas for InhalationPSNb82f163b-c913-431d-88cf-8b6e08d1b42a14
348987nitrogen 99.9 % Gas for InhalationSCDb82f163b-c913-431d-88cf-8b6e08d1b42a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10304-601-0110304060101116495 L in 1 DEWAR (10304-601-01) 116495 l2000-06-120000-00-00NoNoCurrent
10304-601-0210304060102114739 L in 1 DEWAR (10304-601-02) 114739 l2000-06-120000-00-00NoNoCurrent
10304-601-03103040601036512 L in 1 CYLINDER (10304-601-03) 6512 l2000-06-120000-00-00NoNoCurrent