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United States · US · US:70121-2484_6fb2ce70-c98f-4e46-9b0f-6aec0530f61d

BORUZU

Orange BookUNIISPLATC L01XG01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01XG01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7012124841
    1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2484-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
N212782
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "69G8BD63PP",
    "rxcui": "358258",
    "inchikey": "GXJABQQUPOEUTA-RDJZCZTQSA-N",
    "display_name": "BORTEZOMIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "b92628dd-fa09-4c3a-b6a3-66426025807c": {
      "match": "brand_token",
      "title": "BORUZU (BORTEZOMIB) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "2",
      "published_date": "2025-08-08"
    }
  },
  "productid": "70121-2484_6fb2ce70-c98f-4e46-9b0f-6aec0530f61d",
  "productndc": "70121-2484",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212782",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "3.5MG/1.4ML (2.5MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 26, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BORTEZOMIB",
  "proprietary_name": "BORUZU",
  "active_ingred_unit": "mg/1.4mL",
  "application_number": "NDA212782",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bortezomib",
  "start_marketing_date": "20240927",
  "active_numerator_strength": "3.5"
}

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