FDA.reportPublic FDA data

Nitrogen

Product NDC
10942-2010
Requested package NDC
10942-2010-2
11-digit product format
109422010
Labeler code
10942
Product ID
10942-2010_4266ac1c-a6fa-4aee-e063-6294a90aa07a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Raimy Corporation
Application
NDA205866
Marketing category
NDA
Marketing start
2018-02-27
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
9af1adde-4612-2b8d-e053-2a95a90a8c88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10942-2010-1Nitrogen8608.32 L in 1 CYLINDERGAS8608.328
10942-2010-2Nitrogen6456.24 L in 1 CYLINDERGAS6456.248
10942-2010-3Nitrogen4020.99 L in 1 CYLINDERGAS4020.998
10942-2010-4Nitrogen2152.08 L in 1 CYLINDERGAS2152.088
10942-2010-5Nitrogen114683.23 L in 1 CYLINDERGAS114683.238
10942-2010-6Nitrogen111285.21 L in 1 CYLINDERGAS111285.218
10942-2010-7Nitrogen957 L in 1 CYLINDERGAS9578
10942-2010-8Nitrogen160 L in 1 DEWARGAS1608
10942-2010-9Nitrogen180 L in 1 DEWARGAS1808

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10942-2010NITROGEN GAS [RAIMY CORPORATION]7Current NDC, Legacy NDC, 9 package rows20241220_9af1adde-4612-2b8d-e053-2a95a90a8c88.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
311998nitrogen 99 % Gas for InhalationPSN9af1adde-4612-2b8d-e053-2a95a90a8c888
311998nitrogen 99 % Gas for InhalationSCD9af1adde-4612-2b8d-e053-2a95a90a8c888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10942-2010-2109422010026456.24 L in 1 CYLINDER (10942-2010-2) 6456.24 l2018-02-270000-00-00NoNoCurrent