epoprostenol

Generic: epoprostenol

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epoprostenol
Generic Name epoprostenol
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

epoprostenol 1.5 mg/10mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-588
Product ID 67457-588_2a163b77-9e01-4516-b19c-f5a12ce48560
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213913
Listing Expiration 2026-12-31
Marketing Start 2024-09-25

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 67457588
Hyphenated Format 67457-588

Supplemental Identifiers

RxCUI
562501 562502
UPC
0367457587103
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 epoprostenol (source: ndc)
Generic Name epoprostenol (source: ndc)
Application Number ANDA213913 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-588-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

67457-588-10 1 VIAL in 1 CARTON (67457-588-10) / 10 mL in 1 VIAL

Ingredients (1)

epoprostenol (1.5 mg/10mL)

Linked Drug Pages (1)

EPOPROSTENOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2a163b77-9e01-4516-b19c-f5a12ce48560", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "upc": ["0367457587103"], "unii": ["DCR9Z582X0"], "rxcui": ["562501", "562502"], "spl_set_id": ["2a163b77-9e01-4516-b19c-f5a12ce48560"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-588-10)  / 10 mL in 1 VIAL", "package_ndc": "67457-588-10", "marketing_start_date": "20240925"}], "brand_name": "EPOPROSTENOL", "product_id": "67457-588_2a163b77-9e01-4516-b19c-f5a12ce48560", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "67457-588", "generic_name": "EPOPROSTENOL", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EPOPROSTENOL", "active_ingredients": [{"name": "EPOPROSTENOL", "strength": "1.5 mg/10mL"}], "application_number": "ANDA213913", "marketing_category": "ANDA", "marketing_start_date": "20240925", "listing_expiration_date": "20261231"}