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United States · US · US:17156-210_900b7272-7f13-43ef-9320-bc63ccc1434b

DaTscan

Orange BookUNIISPLATC V09AB03

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

Identification

ManufacturerMedi-Physics Inc. dba GE Healthcare.
CountryUS (United States)
ATC codeV09AB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1715621001
    1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
3MM99T8R5Q
IOFLUPANE I-123
RxCUI 1426874
Orange Book
N022454
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3MM99T8R5Q",
    "rxcui": "1426874",
    "inchikey": "HXWLAJVUJSVENX-HFIFKADTSA-N",
    "display_name": "IOFLUPANE I-123",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ef7804d7-c691-495b-8aaf-5bc54fd5d9f6": {
      "match": "brand_token",
      "title": "DATSCAN (IOFLUPANE I-123) INJECTION, SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.]",
      "spl_version": "17",
      "published_date": "2026-04-27"
    }
  },
  "productid": "17156-210_900b7272-7f13-43ef-9320-bc63ccc1434b",
  "productndc": "17156-210",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022454",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5mCi/2.5ML (2mCi/ML)",
        "product_no": "001",
        "approval_date": "Jan 14, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IOFLUPANE I-123",
  "proprietary_name": "DaTscan",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA022454",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ioflupane I-123",
  "start_marketing_date": "20110301",
  "active_numerator_strength": "2"
}

Related drugs

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