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United States · US · US:70511-162_2cc294fe-75e3-4ed9-8259-c6e5bc5e8286

Bortezomib

Orange BookUNIISPLATC L01XG01

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

Identification

ManufacturerMAIA Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XG01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051116202
    1 INJECTION in 1 VIAL, SINGLE-DOSE (70511-162-02)

Annotations

UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
N215331
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",
  "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": "70511-162_2cc294fe-75e3-4ed9-8259-c6e5bc5e8286",
  "productndc": "70511-162",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215331",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3.5MG/3.5ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 27, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3.5MG/1.4ML (2.5MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 27, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BORTEZOMIB",
  "proprietary_name": "Bortezomib",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215331",
  "marketing_category": "NDA",
  "nonproprietary_name": "bortezomib",
  "start_marketing_date": "20220810",
  "active_numerator_strength": "2.5"
}

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