Epoprostenol

Orange BookUNIISPLATC B01AC09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeB01AC09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808364201
1 VIAL in 1 CARTON (68083-642-01) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

DCR9Z582X0

EPOPROSTENOL

RxCUI 8814

Orange Book

A219237

AP2AP2

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "DCR9Z582X0",
    "rxcui": "8814",
    "inchikey": "KAQKFAOMNZTLHT-OZUDYXHBSA-N",
    "display_name": "EPOPROSTENOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "47f64fcd-cbf7-457a-9548-661fb10ff7e0": {
      "match": "brand_token",
      "title": "EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]",
      "spl_version": "5",
      "published_date": "2026-01-07"
    }
  },
  "productid": "68083-642_8b45ebae-92d6-4a3b-a559-115c66a8352a",
  "productndc": "68083-642",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "219237",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "EQ 0.5MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 29, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "EQ 1.5MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 29, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPOPROSTENOL",
  "proprietary_name": "Epoprostenol",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA219237",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Epoprostenol",
  "start_marketing_date": "20251229",
  "active_numerator_strength": "1.5"
}

Related drugs

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