eribulin mesylate

Orange BookUNIISPLATC L01XX41

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeL01XX41

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808359201
1 VIAL, SINGLE-DOSE in 1 CARTON (68083-592-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

AV9U0660CW

ERIBULIN MESYLATE

RxCUI 1045452

Orange Book

A218047

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": {
    "4d3a9ac3-10e9-cad5-e063-6394a90a461f": {
      "match": "brand_token",
      "title": "ERIBULIN MESYLATE INJECTION [XGEN PHARMACEUTICALS DJB, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-08"
    }
  },
  "productid": "68083-592_5db5b24e-3893-4985-a658-731cb840eb76",
  "productndc": "68083-592",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "218047",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/2ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERIBULIN MESYLATE",
  "proprietary_name": "eribulin mesylate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218047",
  "marketing_category": "ANDA",
  "nonproprietary_name": "eribulin mesylate",
  "start_marketing_date": "20240405",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code L01XX41.

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