epoprostenol

Orange BookUNIISPLATC B01AC09

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeB01AC09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6275606040
1 VIAL in 1 CARTON (62756-060-40) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

4K04IQ1OF4

EPOPROSTENOL SODIUM

RxCUI 104463

Orange Book

A210473

AP2AP2

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4K04IQ1OF4",
    "rxcui": "104463",
    "inchikey": "LMHIPJMTZHDKEW-XQYLJSSYSA-M",
    "display_name": "EPOPROSTENOL SODIUM",
    "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": "62756-060_fae129b5-c1b5-45f2-864c-eee72f289334",
  "productndc": "62756-060",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210473",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP2",
        "strength": "EQ 0.5MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jan 15, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "EQ 1.5MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jan 15, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPOPROSTENOL SODIUM",
  "proprietary_name": "epoprostenol",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA210473",
  "marketing_category": "ANDA",
  "nonproprietary_name": "epoprostenol",
  "start_marketing_date": "20210116",
  "active_numerator_strength": "1.5"
}

Related drugs

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