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United States · US · US:63323-821_f82298bb-9017-4d5b-ada9-3d34e46d18f1

Bortezomib

Orange BookUNIISPLATC L01XG01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01XG01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332382110
    1 VIAL, SINGLE-USE in 1 CARTON (63323-821-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
A209659
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": "63323-821_f82298bb-9017-4d5b-ada9-3d34e46d18f1",
  "productndc": "63323-821",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "209659",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3.5MG/VIAL",
        "product_no": "001",
        "approval_date": "May 2, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BORTEZOMIB",
  "proprietary_name": "Bortezomib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209659",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bortezomib",
  "start_marketing_date": "20220502",
  "active_numerator_strength": "3.5"
}

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