FDA.reportPublic FDA data

Nitric Oxide Nitrogen Mix

Product NDC
67989-011
11-digit product format
679890011
Labeler code
67989
Product ID
67989-011_54e8282d-592d-4a21-ab01-2da34170792e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitric Oxide Nitrogen Mix
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Airgas Specialty Gases
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2010-05-01
Marketing end
0000-00-00
Substance
NITRIC OXIDE; NITROGEN
Active strength
5 mL/L; mL/L
Pharmacologic classes
Vasodilation [PE],Vasodilator [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
46e64ad7-7dca-4816-a2a4-8cdff2136105Product name220240828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67989-011-012019-10-29C16284748780-1960f7f55-c599-8e05-e053-dbdaa90a074aNitric Oxide Nitrogen Mix
67989-011-022019-10-29C16284748780-1960f7f55-c599-8e05-e053-dbdaa90a074aNitric Oxide Nitrogen Mix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67989-011-01Nitric Oxide Nitrogen Mix550 L in 1 CYLINDERGAS5503
67989-011-02Nitric Oxide Nitrogen Mix209.6 L in 1 CYLINDERGAS209.63

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitric OxideACTIVE INGREDIENT31C4KY9ESHNITRIC OXIDE NITROGEN MIX GAS [AIRGAS SPECIALTY GASES]3
NitrogenACTIVE INGREDIENTN762921K75NITRIC OXIDE NITROGEN MIX GAS [AIRGAS SPECIALTY GASES]3
Nitric OxideACTIVE MOIETY31C4KY9ESHNITRIC OXIDE NITROGEN MIX GAS [AIRGAS SPECIALTY GASES]3
NitrogenACTIVE MOIETYN762921K75NITRIC OXIDE NITROGEN MIX GAS [AIRGAS SPECIALTY GASES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67989-011NITRIC OXIDE NITROGEN MIX GAS [AIRGAS SPECIALTY GASES]3Legacy NDC, 2 package rows20110314_30c9e53e-e150-4b16-8b5f-4a1b14678133.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544281nitric oxide 5000 PPM Gas for InhalationPSN30c9e53e-e150-4b16-8b5f-4a1b146781333
1544281nitric oxide 0.5 % / nitrogen 99.5 % Gas for InhalationSCD30c9e53e-e150-4b16-8b5f-4a1b146781333
1544281nitric oxide 5000 PPM (0.5 % ) Gas for InhalationSY30c9e53e-e150-4b16-8b5f-4a1b146781333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67989-011-0167989001101550 L in 1 CYLINDER550 lHistorical
67989-011-0267989001102209.6 L in 1 CYLINDER209.6 lHistorical