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United States · US · US:25208-001_6fae214d-f37d-49ff-b1bb-266584eb664f

AGGRASTAT

Orange BookUNIISPLATC B01AC17

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

Identification

ManufacturerMedicure International Inc
CountryUS (United States)
ATC codeB01AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2520800104
    1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
6H925F8O5J
TIROFIBAN HYDROCHLORIDE
RxCUI 253202
Orange Book
N020912
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6H925F8O5J",
    "rxcui": "253202",
    "inchikey": "HWAAPJPFZPHHBC-FGJQBABTSA-N",
    "display_name": "TIROFIBAN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "e850111f-e713-41a2-9c65-21c517cf5511": {
      "match": "brand_token",
      "title": "AGGRASTAT (TIROFIBAN) INJECTION, SOLUTION [MEDICURE INTERNATIONAL INC]",
      "spl_version": "3",
      "published_date": "2024-12-26"
    }
  },
  "productid": "25208-001_6fae214d-f37d-49ff-b1bb-266584eb664f",
  "productndc": "25208-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)",
        "product_no": "001",
        "approval_date": "May 14, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Aug 31, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIROFIBAN HYDROCHLORIDE",
  "proprietary_name": "AGGRASTAT",
  "active_ingred_unit": "mg/15mL",
  "application_number": "NDA020912",
  "marketing_category": "NDA",
  "nonproprietary_name": "TIROFIBAN",
  "start_marketing_date": "20161015",
  "active_numerator_strength": "3.75"
}

Related drugs

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