veletri

Generic: epoprostenol

Labeler: actelion pharmaceuticals us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name veletri
Generic Name epoprostenol
Labeler actelion pharmaceuticals us, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

epoprostenol 1.5 mg/10mL

Manufacturer
Actelion Pharmaceuticals US, Inc.

Identifiers & Regulatory

Product NDC 66215-402
Product ID 66215-402_39e8b7f8-f82a-4083-a284-ce571a87ce97
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022260
Listing Expiration 2026-12-31
Marketing Start 2010-04-22

Pharmacologic Class

Established (EPC)
prostacycline vasodilator [epc]
Chemical Structure
prostaglandins i [cs]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66215402
Hyphenated Format 66215-402

Supplemental Identifiers

RxCUI
562501 562502 1009216 1302755
UNII
DCR9Z582X0
NUI
N0000175416 M0017817 N0000009909

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name veletri (source: ndc)
Generic Name epoprostenol (source: ndc)
Application Number NDA022260 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (66215-402-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

66215-402-01 1 VIAL in 1 CARTON (66215-402-01) / 10 mL in 1 VIAL

Ingredients (1)

epoprostenol (1.5 mg/10mL)

Linked Drug Pages (1)

Veletri ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "39e8b7f8-f82a-4083-a284-ce571a87ce97", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "unii": ["DCR9Z582X0"], "rxcui": ["562501", "562502", "1009216", "1302755"], "spl_set_id": ["df502787-46ec-4dd1-a2c0-be90f6d95a5d"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Actelion Pharmaceuticals US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (66215-402-01)  / 10 mL in 1 VIAL", "package_ndc": "66215-402-01", "marketing_start_date": "20100422"}], "brand_name": "Veletri", "product_id": "66215-402_39e8b7f8-f82a-4083-a284-ce571a87ce97", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "66215-402", "generic_name": "epoprostenol", "labeler_name": "Actelion Pharmaceuticals US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Veletri", "active_ingredients": [{"name": "EPOPROSTENOL", "strength": "1.5 mg/10mL"}], "application_number": "NDA022260", "marketing_category": "NDA", "marketing_start_date": "20100422", "listing_expiration_date": "20261231"}