epoprostenol

Generic: epoprostenol

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name epoprostenol
Generic Name epoprostenol
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

epoprostenol .5 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-707
Product ID 68083-707_8b45ebae-92d6-4a3b-a559-115c66a8352a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219237
Listing Expiration 2027-12-31
Marketing Start 2025-12-29

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 68083707
Hyphenated Format 68083-707

Supplemental Identifiers

RxCUI
562501 562502
UPC
0368083707019 0368083642013
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 ANDA219237 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-707-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-707-01 1 VIAL in 1 CARTON (68083-707-01) / 10 mL in 1 VIAL

Ingredients (1)

epoprostenol (.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": "8b45ebae-92d6-4a3b-a559-115c66a8352a", "openfda": {"nui": ["N0000175416", "M0017817", "N0000009909"], "upc": ["0368083707019", "0368083642013"], "unii": ["DCR9Z582X0"], "rxcui": ["562501", "562502"], "spl_set_id": ["47f64fcd-cbf7-457a-9548-661fb10ff7e0"], "pharm_class_cs": ["Prostaglandins I [CS]"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Prostacycline Vasodilator [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-707-01)  / 10 mL in 1 VIAL", "package_ndc": "68083-707-01", "marketing_start_date": "20251229"}], "brand_name": "Epoprostenol", "product_id": "68083-707_8b45ebae-92d6-4a3b-a559-115c66a8352a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "68083-707", "generic_name": "Epoprostenol", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Epoprostenol", "active_ingredients": [{"name": "EPOPROSTENOL", "strength": ".5 mg/10mL"}], "application_number": "ANDA219237", "marketing_category": "ANDA", "marketing_start_date": "20251229", "listing_expiration_date": "20271231"}