VENTAVIS
These highlights do not include all the information needed to use VENTAVIS safely and effectively. See full prescribing information for VENTAVIS. VENTAVIS (iloprost) inhalation solution, for oral inhalation use Initial U.S. Approval: 2004
Approved
Approval ID
d3bebc1c-f032-402a-bbc9-aff024276ed1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2022
Manufacturers
FDA
Actelion Pharmaceuticals US, Inc.
DUNS: 002641228
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iloprost
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-302
Application NumberNDA021779
Product Classification
M
Marketing Category
C73594
G
Generic Name
iloprost
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMarch 9, 2022
FDA Product Classification
INGREDIENTS (6)
iloprostActive
Quantity: 10 ug in 1 mL
Code: JED5K35YGL
Classification: ACTIB
alcoholInactive
Code: 3K9958V90M
Classification: IACT
tromethamineInactive
Code: 023C2WHX2V
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
iloprost
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-303
Application NumberNDA021779
Product Classification
M
Marketing Category
C73594
G
Generic Name
iloprost
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMarch 9, 2022
FDA Product Classification
INGREDIENTS (6)
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
iloprostActive
Quantity: 20 ug in 1 mL
Code: JED5K35YGL
Classification: ACTIB
alcoholInactive
Code: 3K9958V90M
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
tromethamineInactive
Code: 023C2WHX2V
Classification: IACT