INOMAX
These highlights do not include all the information needed to use INOMAX safely and effectively. See full prescribing information for INOMAX. INOMAX (nitric oxide) gas, for inhalationInitial U.S. Approval: 1999
Approved
Approval ID
762b51be-1893-4cd1-9511-e645fc420d3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2023
Manufacturers
FDA
INO THERAPEUTICS LLC
DUNS: 090546628
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitric oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64693-002
Application NumberNDA020845
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitric oxide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (1)
nitric oxideActive
Quantity: 0.98 mg in 1 L
Code: 31C4KY9ESH
Classification: ACTIB
nitric oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64693-003
Application NumberNDA020845
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitric oxide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 12, 2023
FDA Product Classification
INGREDIENTS (1)
nitric oxideActive
Quantity: 6 mg in 1 L
Code: 31C4KY9ESH
Classification: ACTIB