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United States · US · US:0078-1217_4d7d1071-153c-4073-9a10-1a4185778dfe

PLUVICTO

Orange BookUNIISPLATC V10XX05

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeV10XX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078121761
    1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
G6UF363ECX
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
RxCUI 2597053
Orange Book
N215833
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G6UF363ECX",
    "rxcui": "2597053",
    "inchikey": "RSTDSVVLNYFDHY-BGOLSCJMSA-K",
    "display_name": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "14908037-2892-4d98-a053-253ce35afb1a": {
      "match": "brand_token",
      "title": "PLUVICTO (LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN) INJECTION, SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "3",
      "published_date": "2026-04-17"
    }
  },
  "productid": "0078-1217_4d7d1071-153c-4073-9a10-1a4185778dfe",
  "productndc": "0078-1217",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215833",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "27mCi/ML",
        "product_no": "001",
        "approval_date": "Mar 23, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN",
  "proprietary_name": "PLUVICTO",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA215833",
  "marketing_category": "NDA",
  "nonproprietary_name": "lutetium Lu 177 vipivotide tetraxetan",
  "start_marketing_date": "20220323",
  "active_numerator_strength": "27"
}

Related drugs

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