IXEMPRA

Orange BookSPL

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

Identification

ManufacturerR-Pharm US Operating, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7002019111
1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE

Annotations

Orange Book

N022065

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "241f0b1e-8b95-470d-876f-bf1804daaf18": {
      "match": "brand_token",
      "title": "IXEMPRA (IXABEPILONE) KIT [R-PHARM US OPERATING, LLC]",
      "spl_version": "13",
      "published_date": "2025-12-05"
    }
  },
  "productid": "70020-1911_452ab301-102b-ac80-e063-6394a90ab113",
  "productndc": "70020-1911",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022065",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "15MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 16, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "45MG/VIAL",
        "product_no": "002",
        "approval_date": "Oct 16, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "IXEMPRA",
  "active_ingred_unit": null,
  "application_number": "NDA022065",
  "marketing_category": "NDA",
  "nonproprietary_name": "ixabepilone",
  "start_marketing_date": "20071016",
  "active_numerator_strength": null
}

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