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United States · US · US:81298-3890_68589863-7488-4661-bbbe-9838b7d0396d

Eribulin Mesylate

Orange BookUNIISPLATC L01XX41

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerLong Grove Pharmaceuticals, LLC
CountryUS (United States)
ATC codeL01XX41
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8129838901
    1 VIAL, SINGLE-DOSE in 1 CARTON (81298-3890-1) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
AV9U0660CW
ERIBULIN MESYLATE
RxCUI 1045452
Orange Book
A214850
AP
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": "81298-3890_68589863-7488-4661-bbbe-9838b7d0396d",
  "productndc": "81298-3890",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214850",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/2ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 18, 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": "ANDA214850",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Eribulin Mesylate",
  "start_marketing_date": "20240722",
  "active_numerator_strength": ".5"
}

Related drugs

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