Halaven

Orange BookUNIISPLATC L01XX41

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

Identification

ManufacturerBSP Pharmaceuticals SpA

CountryUS (United States)

ATC codeL01XX41

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4362400201
100 VIAL in 1 TRAY (43624-002-01) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

AV9U0660CW

ERIBULIN MESYLATE

RxCUI 1045452

Orange Book

N201532

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "AV9U0660CW",
    "rxcui": "1045452",
    "inchikey": "QAMYWGZHLCQOOJ-WRNBYXCMSA-N",
    "display_name": "ERIBULIN MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6": {
      "match": "brand_token",
      "title": "HALAVEN (ERIBULIN MESYLATE) INJECTION [BSP PHARMACEUTICALS SPA]",
      "spl_version": "58",
      "published_date": "2026-05-14"
    }
  },
  "productid": "43624-002_494dbaab-6ded-549d-e063-6394a90a4022",
  "productndc": "43624-002",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "201532",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/2ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 15, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERIBULIN MESYLATE",
  "proprietary_name": "Halaven",
  "active_ingred_unit": "mg/2mL",
  "application_number": "NDA201532",
  "marketing_category": "NDA",
  "nonproprietary_name": "eribulin mesylate",
  "start_marketing_date": "20170421",
  "active_numerator_strength": "1"
}

Related drugs

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