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United States · US · US:66215-402_39e8b7f8-f82a-4083-a284-ce571a87ce97

Veletri

Orange BookUNIIATC B01AC09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerActelion Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeB01AC09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6621540201
    1 VIAL in 1 CARTON (66215-402-01) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
DCR9Z582X0
EPOPROSTENOL
RxCUI 8814
Orange Book
N022260
AP2AP2
Raw payload (JSON)
{
  "unii": {
    "unii": "DCR9Z582X0",
    "rxcui": "8814",
    "inchikey": "KAQKFAOMNZTLHT-OZUDYXHBSA-N",
    "display_name": "EPOPROSTENOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "66215-402_39e8b7f8-f82a-4083-a284-ce571a87ce97",
  "productndc": "66215-402",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "022260",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP2",
        "strength": "EQ 1.5MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jun 27, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP2",
        "strength": "EQ 0.5MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jun 28, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPOPROSTENOL",
  "proprietary_name": "Veletri",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA022260",
  "marketing_category": "NDA",
  "nonproprietary_name": "epoprostenol",
  "start_marketing_date": "20100422",
  "active_numerator_strength": "1.5"
}

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