NDC 66215-403

Veletri

Epoprostenol

Veletri is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Actelion Pharmaceuticals Us, Inc.. The primary component is Epoprostenol.

• Product ID: 66215-403_1bec1b5a-5956-4b0a-b46e-c85a051d1631
• NDC: 66215-403
• Product Type: Human Prescription Drug
• Proprietary Name: Veletri
• Generic Name: Epoprostenol
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-04-22
• Marketing Category: NDA / NDA
• Application Number: NDA022260
• Labeler Name: Actelion Pharmaceuticals US, Inc.
• Substance Name: EPOPROSTENOL
• Active Ingredient Strength: 1 mg/10mL
• Pharm Classes: Prostacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 66215-403-01

1 VIAL in 1 CARTON (66215-403-01) > 10 mL in 1 VIAL

• Marketing Start Date: 2010-04-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66215-403-01 [66215040301]

Veletri INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022260
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-22

Drug Details

Active Ingredients

Ingredient	Strength
EPOPROSTENOL	.5 mg/10mL

OpenFDA Data

• SPL SET ID: df502787-46ec-4dd1-a2c0-be90f6d95a5d
• Manufacturer:
  • Actelion Pharmaceuticals US, Inc.
• UNII:
  • DCR9Z582X0
• RxNorm Concept Unique ID - RxCUI:
  • 1302755
  • 562501
  • 562502
  • 1009216

Pharmacological Class

• Prostacycline Vasodilator [EPC]
• Prostaglandins I [CS]
• Vasodilation [PE]
• Prostacycline Vasodilator [EPC]
• Prostaglandins I [CS]
• Vasodilation [PE]

NDC Crossover Matching brand name "Veletri" or generic name "Epoprostenol"

NDC	Brand Name	Generic Name
66215-402	Veletri	epoprostenol
66215-403	Veletri	epoprostenol
62756-059	epoprostenol	epoprostenol
62756-060	epoprostenol	epoprostenol