🇺🇸
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
- ndc1125208001041 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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