Package 68083-707-01

Brand: epoprostenol

Generic: epoprostenol
NDC Package

Package Facts

Identity

Package NDC 68083-707-01
Digits Only 6808370701
Product NDC 68083-707
Description

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

Marketing

Marketing Status
Marketed Since 2025-12-29
Brand epoprostenol
Generic epoprostenol
Sample Package No

Linked Drug Pages (1)

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"}