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United States · US · US:0078-1224_8683b06e-4901-4526-89ad-23a8fe2d1331

LOCAMETZ

Orange BookUNIISPLATC V09IX

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation
CountryUS (United States)
ATC codeV09IX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0078122461
    1 VIAL, MULTI-DOSE in 1 CARTON (0078-1224-61) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
9AG41L3AOQ
GOZETOTIDE
RxCUI 2588949
Orange Book
N215841
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9AG41L3AOQ",
    "rxcui": "2588949",
    "inchikey": "QJUIUFGOTBRHKP-LQJZCPKCSA-N",
    "display_name": "GOZETOTIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "8683b06e-4901-4526-89ad-23a8fe2d1331": {
      "match": "brand_token",
      "title": "LOCAMETZ (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "1",
      "published_date": "2026-01-16"
    }
  },
  "productid": "0078-1224_8683b06e-4901-4526-89ad-23a8fe2d1331",
  "productndc": "0078-1224",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "215841",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Mar 23, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GOZETOTIDE",
  "proprietary_name": "LOCAMETZ",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA215841",
  "marketing_category": "NDA",
  "nonproprietary_name": "kit for the preparation of gallium Ga 68 gozetotide",
  "start_marketing_date": "20220323",
  "active_numerator_strength": "25"
}

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