Veletri
These highlights do not include all the information needed to use VELETRI safely and effectively. See full prescribing information for VELETRI. VELETRI (epoprostenol) for injection, for intravenous use Initial U.S. Approval: 1995
Approved
Approval ID
df502787-46ec-4dd1-a2c0-be90f6d95a5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 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.
epoprostenol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-402
Application NumberNDA022260
Product Classification
M
Marketing Category
C73594
G
Generic Name
epoprostenol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (4)
epoprostenolActive
Quantity: 1.5 mg in 10 mL
Code: DCR9Z582X0
Classification: ACTIB
arginineInactive
Code: 94ZLA3W45F
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
epoprostenol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66215-403
Application NumberNDA022260
Product Classification
M
Marketing Category
C73594
G
Generic Name
epoprostenol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 31, 2022
FDA Product Classification
INGREDIENTS (4)
arginineInactive
Code: 94ZLA3W45F
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
epoprostenolActive
Quantity: 0.5 mg in 10 mL
Code: DCR9Z582X0
Classification: ACTIB
sucroseInactive
Code: C151H8M554
Classification: IACT