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United States · US · US:70069-836_34c615d6-ddc9-c4b5-e063-6294a90a047f

Bortezomib

Orange BookUNIISPLATC L01XG01

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

Identification

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

Packs · 1

  • ndc11
    7006983601
    1 VIAL in 1 CARTON (70069-836-01) / 3.5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
A211898
AP
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": {
    "decb5d94-2ea2-48d8-b08b-3196b24c0ed3": {
      "match": "brand_token",
      "title": "BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVENACY, LLC]",
      "spl_version": "1",
      "published_date": "2026-05-01"
    }
  },
  "productid": "70069-836_34c615d6-ddc9-c4b5-e063-6294a90a047f",
  "productndc": "70069-836",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211898",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3.5MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 11, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BORTEZOMIB",
  "proprietary_name": "Bortezomib",
  "active_ingred_unit": "mg/3.5mL",
  "application_number": "ANDA211898",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bortezomib",
  "start_marketing_date": "20250429",
  "active_numerator_strength": "3.5"
}

Related drugs

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