Tirofiban

Orange BookUNIISPLATC B01AC17

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC codeB01AC17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515043001
1 POUCH in 1 CARTON (55150-430-01) / 1 BAG in 1 POUCH / 250 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

6H925F8O5J

TIROFIBAN HYDROCHLORIDE

RxCUI 253202

Orange Book

A216379

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": {
    "7731e46a-2121-441b-b090-12dcefe240f0": {
      "match": "brand_token",
      "title": "TIROFIBAN HYDROCHLORIDE INJECTION [NEXUS PHARMACEUTICALS LLC]",
      "spl_version": "10",
      "published_date": "2025-02-21"
    }
  },
  "productid": "55150-430_1751523a-e22e-4faf-bdb1-c850afe2fd36",
  "productndc": "55150-430",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216379",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)",
        "product_no": "001",
        "approval_date": "May 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)",
        "product_no": "002",
        "approval_date": "May 1, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIROFIBAN HYDROCHLORIDE",
  "proprietary_name": "Tirofiban",
  "active_ingred_unit": "mg/250mL",
  "application_number": "ANDA216379",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tirofiban",
  "start_marketing_date": "20230501",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code B01AC17.

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