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United States · US · US:70710-1411_1d5e9573-97a5-4d8e-a9b1-80750b9870b3

BORTEZOMIB

Orange BookUNIISPLATC L01XG01

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

Identification

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

Packs · 1

  • ndc11
    7071014111
    1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1411-1) / 3.5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
A210204
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": "70710-1411_1d5e9573-97a5-4d8e-a9b1-80750b9870b3",
  "productndc": "70710-1411",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "210204",
    "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/mL",
  "application_number": "ANDA210204",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BORTEZOMIB",
  "start_marketing_date": "20220502",
  "active_numerator_strength": "1"
}

Related drugs

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