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United States · US · US:24417-681_d8871970-cf1c-4cd2-86ed-0565c0dfb5cc

Ga-68-DOTATOC

Orange BookUNIIATC V09IX09

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

Identification

ManufacturerUIHC � P E T Imaging Center
CountryUS (United States)
ATC codeV09IX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2441768130
    14 mL in 1 VIAL, MULTI-DOSE (24417-681-30)

Annotations

UNII (FDA Substance ID)
Y68179SY2L
EDOTREOTIDE GALLIUM GA-68
RxCUI 2199391
Orange Book
N210828
AP
Raw payload (JSON)
{
  "unii": {
    "unii": "Y68179SY2L",
    "rxcui": "2199391",
    "inchikey": "PZBPHYLKIMOZPR-FIYGWYQWSA-K",
    "display_name": "EDOTREOTIDE GALLIUM GA-68",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "24417-681_d8871970-cf1c-4cd2-86ed-0565c0dfb5cc",
  "productndc": "24417-681",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210828",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5-4mCi/ML",
        "product_no": "001",
        "approval_date": "Aug 21, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EDOTREOTIDE GALLIUM GA-68",
  "proprietary_name": "Ga-68-DOTATOC",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA210828",
  "marketing_category": "NDA",
  "nonproprietary_name": "EDOTREOTIDE GALLIUM GA-68",
  "start_marketing_date": "20190901",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code V09IX09.

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