AGGRASTAT

Orange BookUNIISPLATC B01AC17

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

Identification

ManufacturerMedicure International Inc

CountryUS (United States)

ATC codeB01AC17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
2520800201
1 BAG in 1 CARTON (25208-002-01) / 100 mL in 1 BAG
ndc11
2520800202
1 CONTAINER in 1 CARTON (25208-002-02) / 250 mL in 1 CONTAINER

Annotations

UNII (FDA Substance ID)

6H925F8O5J

TIROFIBAN HYDROCHLORIDE

RxCUI 253202

Orange Book

N020913

APAP

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": "25208-002_6fae214d-f37d-49ff-b1bb-266584eb664f",
  "productndc": "25208-002",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "020913",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)",
        "product_no": "001",
        "approval_date": "May 14, 1998"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)",
        "product_no": "002",
        "approval_date": "May 17, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Apr 20, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIROFIBAN HYDROCHLORIDE",
  "proprietary_name": "AGGRASTAT",
  "active_ingred_unit": "mg/100mL",
  "application_number": "NDA020913",
  "marketing_category": "NDA",
  "nonproprietary_name": "TIROFIBAN",
  "start_marketing_date": "19980514",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code B01AC17.

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