FDA.reportPublic FDA data

NITROGEN

Product NDC
10218-102
11-digit product format
102180102
Labeler code
10218
Product ID
10218-102_4bae4903-6d73-0bf3-e063-6394a90a14d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGEN
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
CEE-KAY SUPPLY, INC.
Application
NDA205766
Marketing category
NDA
Marketing start
1997-04-05
Substance
NITROGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
53f88c55-5c28-4a93-852b-894b0999e27dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10218-102-01NITROGEN8500 L in 1 CYLINDERGAS850022
10218-102-02NITROGEN6000 L in 1 CYLINDERGAS600022
10218-102-03NITROGEN3000 L in 1 CYLINDERGAS300022
10218-102-04NITROGEN2000 L in 1 CYLINDERGAS200022
10218-102-05NITROGEN1000 L in 1 CYLINDERGAS100022
10218-102-06NITROGEN650 L in 1 CYLINDERGAS65022
10218-102-07NITROGEN400 L in 1 CYLINDERGAS40022
10218-102-08NITROGEN177 L in 1 DEWARGAS17722
10218-102-09NITROGEN146 L in 1 DEWARGAS14622
10218-102-10NITROGEN230 L in 1 DEWARGAS23022
10218-102-11NITROGEN196 L in 1 DEWARGAS19622

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGENACTIVE INGREDIENTN762921K75NITROGEN GAS [CEE-KAY SUPPLY, INC.]10
NITROGENACTIVE MOIETYN762921K75NITROGEN GAS [CEE-KAY SUPPLY, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10218-102NITROGEN GAS [CEE-KAY SUPPLY, INC.]20Current NDC, Legacy NDC, 11 package rows20241023_53f88c55-5c28-4a93-852b-894b0999e27d.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 InhalationPSN53f88c55-5c28-4a93-852b-894b0999e27d22
347021nitrogen 99.5 % Gas for InhalationSCD53f88c55-5c28-4a93-852b-894b0999e27d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10218-102-01102180102018500 L in 1 CYLINDER (10218-102-01) 8500 l1997-04-050000-00-00NoNoCurrent
10218-102-02102180102026000 L in 1 CYLINDER (10218-102-02) 6000 l1997-04-050000-00-00NoNoCurrent
10218-102-03102180102033000 L in 1 CYLINDER (10218-102-03) 3000 l1997-04-050000-00-00NoNoCurrent
10218-102-04102180102042000 L in 1 CYLINDER (10218-102-04) 2000 l1997-04-050000-00-00NoNoCurrent
10218-102-05102180102051000 L in 1 CYLINDER (10218-102-05) 1000 l1997-04-050000-00-00NoNoCurrent
10218-102-0610218010206650 L in 1 CYLINDER (10218-102-06) 650 l1997-04-050000-00-00NoNoCurrent
10218-102-0710218010207400 L in 1 CYLINDER (10218-102-07) 400 l1997-04-050000-00-00NoNoCurrent
10218-102-0810218010208177 L in 1 DEWAR (10218-102-08) 177 l1997-04-050000-00-00NoNoCurrent
10218-102-0910218010209146 L in 1 DEWAR (10218-102-09) 146 l1997-04-050000-00-00NoNoCurrent
10218-102-1010218010210230 L in 1 DEWAR (10218-102-10) 230 l1997-04-05NoNoCurrent
10218-102-1110218010211196 L in 1 DEWAR (10218-102-11) 196 l1997-04-05NoNoCurrent