flolan

Generic: epoprostenol sodium

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name flolan
Generic Name epoprostenol sodium
Labeler glaxosmithkline llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

epoprostenol sodium 1.5 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 0173-0519
Product ID 0173-0519_38b7a328-0fa3-409f-b230-16bcbc8f4798
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020444
Marketing Start 1995-12-08
Marketing End 2026-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01730519
Hyphenated Format 0173-0519

Supplemental Identifiers

RxCUI
211199 211200 562501 562502
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 flolan (source: ndc)
Generic Name epoprostenol sodium (source: ndc)
Application Number NDA020444 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00)
source: ndc

Packages (1)

0173-0519-00 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00)

Ingredients (1)

epoprostenol sodium (1.5 mg/1)

Linked Drug Pages (1)

FLOLAN, Diluent ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "38b7a328-0fa3-409f-b230-16bcbc8f4798", "openfda": {"unii": ["4K04IQ1OF4"], "rxcui": ["211199", "211200", "562501", "562502"], "spl_set_id": ["8e4b636e-ee9c-4111-779d-28c8369d283b"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00)", "package_ndc": "0173-0519-00", "marketing_end_date": "20260531", "marketing_start_date": "19951208"}], "brand_name": "FLOLAN", "product_id": "0173-0519_38b7a328-0fa3-409f-b230-16bcbc8f4798", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Prostacycline Vasodilator [EPC]", "Prostaglandins I [CS]", "Vasodilation [PE]"], "product_ndc": "0173-0519", "generic_name": "epoprostenol sodium", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLOLAN", "active_ingredients": [{"name": "EPOPROSTENOL SODIUM", "strength": "1.5 mg/1"}], "application_number": "NDA020444", "marketing_category": "NDA", "marketing_end_date": "20260531", "marketing_start_date": "19951208"}