epoprostenol

Generic: epoprostenol

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epoprostenol
Generic Name epoprostenol
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

epoprostenol sodium 1.5 mg/10mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-060
Product ID 62756-060_fae129b5-c1b5-45f2-864c-eee72f289334
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210473
Listing Expiration 2026-12-31
Marketing Start 2021-01-16

Pharmacologic Class

Classes
prostacycline vasodilator [epc] prostaglandins i [cs] vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756060
Hyphenated Format 62756-060

Supplemental Identifiers

RxCUI
562501 562502
UPC
0362756059405 0362756060401
UNII
4K04IQ1OF4

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 ANDA210473 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (62756-060-40) / 10 mL in 1 VIAL
source: ndc

Packages (1)

62756-060-40 1 VIAL in 1 CARTON (62756-060-40) / 10 mL in 1 VIAL

Ingredients (1)

epoprostenol sodium (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": "fae129b5-c1b5-45f2-864c-eee72f289334", "openfda": {"upc": ["0362756059405", "0362756060401"], "unii": ["4K04IQ1OF4"], "rxcui": ["562501", "562502"], "spl_set_id": ["db57e498-db20-45e8-8298-b0cf0811d270"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (62756-060-40)  / 10 mL in 1 VIAL", "package_ndc": "62756-060-40", "marketing_start_date": "20210116"}], "brand_name": "epoprostenol", "product_id": "62756-060_fae129b5-c1b5-45f2-864c-eee72f289334", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "62756-060", "generic_name": "epoprostenol", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "epoprostenol", "active_ingredients": [{"name": "EPOPROSTENOL SODIUM", "strength": "1.5 mg/10mL"}], "application_number": "ANDA210473", "marketing_category": "ANDA", "marketing_start_date": "20210116", "listing_expiration_date": "20261231"}