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United States · US · US:63020-049_3ec85e73-696a-4a2e-aa24-656c6341b23b

VELCADE

Orange BookUNIISPLATC L01XG01

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

Identification

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

Packs · 1

  • ndc11
    6302004901
    1 VIAL in 1 CARTON (63020-049-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
69G8BD63PP
BORTEZOMIB
RxCUI 358258
Orange Book
N021602
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": {
    "1521d321-e724-4ffc-adad-34bf4f44fac7": {
      "match": "brand_token",
      "title": "VELCADE (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "36",
      "published_date": "2025-09-01"
    }
  },
  "productid": "63020-049_3ec85e73-696a-4a2e-aa24-656c6341b23b",
  "productndc": "63020-049",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "021602",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "3.5MG/VIAL",
        "product_no": "001",
        "approval_date": "May 13, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BORTEZOMIB",
  "proprietary_name": "VELCADE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021602",
  "marketing_category": "NDA",
  "nonproprietary_name": "bortezomib",
  "start_marketing_date": "20030513",
  "active_numerator_strength": "3.5"
}

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