INOMAX

Product NDC
64693-002
11-digit product format
646930002
Labeler code
64693
Product ID
64693-002_6fa12acd-30da-4725-953d-68a30b52b66a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitric oxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
INO Therapeutics LLC
Application
NDA020845
Marketing category
NDA
Marketing start
1999-12-23
Substance
NITRIC OXIDE
Active strength
.98 mg/L
Pharmacologic classes
Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INOMAX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITRIC OXIDE.98 mg/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31C4KY9ESH
Rxcui582608, 827693

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64693-002-01INOMAX353 L in 1 CYLINDERGAS35319
64693-002-01INOMAX1 in 1 CARTONGAS119
64693-002-02INOMAX1963 L in 1 CYLINDERGAS196319
64693-002-02INOMAX1 in 1 CARTONGAS119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64693-002-01EA - Each64693-0021d433e85-27c7-4261-9a4f-9ac516339d9a12015-10-02
64693-002-02EA - Each64693-00288b33d9b-b98a-4681-b6aa-5590ef9b4c5912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitric oxideACTIVE INGREDIENT31C4KY9ESHINOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS]12
nitric oxideACTIVE MOIETY31C4KY9ESHINOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64693-002INOMAX (NITRIC OXIDE) GAS [INO THERAPEUTICS LLC]18Current NDC, Legacy NDC, 4 package rows20241211_762b51be-1893-4cd1-9511-e645fc420d3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
827693INOmax 800 PPM Gas for InhalationPSN762b51be-1893-4cd1-9511-e645fc420d3a19
582608nitric oxide 800 PPM Gas for InhalationPSN762b51be-1893-4cd1-9511-e645fc420d3a19
827693nitric oxide 0.08 % / nitrogen 99.92 % Gas for Inhalation [INOmax]SBD762b51be-1893-4cd1-9511-e645fc420d3a19
582608nitric oxide 0.08 % / nitrogen 99.92 % Gas for InhalationSCD762b51be-1893-4cd1-9511-e645fc420d3a19
827693INOmax 0.08 % / 99.92 % Gas for InhalationSY762b51be-1893-4cd1-9511-e645fc420d3a19
827693INOmax 800 PPM Gas for InhalationSY762b51be-1893-4cd1-9511-e645fc420d3a19
582608nitric oxide 800 PPM Gas for InhalationSY762b51be-1893-4cd1-9511-e645fc420d3a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64693-002-01646930002011 CYLINDER in 1 CARTON (64693-002-01) / 353 L in 1 CYLINDER1 cylinder1999-12-230000-00-00NoNoCurrent
64693-002-02646930002021 CYLINDER in 1 CARTON (64693-002-02) / 1963 L in 1 CYLINDER1 cylinder1999-12-230000-00-00NoNoCurrent