NDC Code(s) : 66215-401-01
Packager : Actelion Pharmaceuticals US, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Veletriepoprostenol sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66215-401
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epoprostenol sodium(UNII: 4K04IQ1OF4)
(epoprostenol - UNII:DCR9Z582X0) 		epoprostenol sodium1500000 ng in 10 mL
Inactive Ingredients
Ingredient Name Strength
arginine(UNII: 94ZLA3W45F)50 mg in 10 mL
mannitol(UNII: 3OWL53L36A)50 mg in 10 mL
sodium hydroxide(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66215-401-011 in 1 CARTON
110 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022260 04/22/2010

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 1.5 mg Vial Carton

NDC 66215-401-01
Single Dose Vial

VELETRI®
epoprostenol for Injection

1.5 mg (1,500,000 ng)/ vial

Sterile, Lyophilized Product
For Intravenous Infusion Only

Rx Only

ACTELION

Principal Display Panel - 1.5 mg Vial Carton