INOMAX

Product NDC
64693-003
11-digit product format
646930003
Labeler code
64693
Product ID
64693-003_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
2023-01-17
Substance
NITRIC OXIDE
Active strength
6 mg/L
Pharmacologic classes
Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
31C4KY9ESHNITRIC OXIDE10102-43-9NITRIC OXIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64693-003-016469300030178 L in 1 CYLINDER (64693-003-01) 78 l2023-01-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
INOMAX - INO Therapeutics LLCINO Therapeutics LLC2025-12-12HUMAN PRESCRIPTION DRUG LABEL19