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United States · US · US:69932-002_3f8e1fd0-31f4-4279-e063-6394a90abead

POSLUMA

Orange BookUNIISPLATC V09IX18

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

Identification

ManufacturerBlue Earth Diagnostics
CountryUS (United States)
ATC codeV09IX18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6993200250
    25 mL in 1 VIAL, MULTI-DOSE (69932-002-50)

Annotations

UNII (FDA Substance ID)
811W19E3OL
FLOTUFOLASTAT F-18
Orange Book
N216023
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "811W19E3OL",
    "rxcui": null,
    "inchikey": "QMGJNAVROCDAIW-MQNQVPOESA-N",
    "display_name": "FLOTUFOLASTAT F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "907ac4a4-a088-4826-ab50-cfc31985c9d4": {
      "match": "brand_token",
      "title": "POSLUMA (FLOTUFOLASTAT F-18) INJECTION [BLUE EARTH DIAGNOSTICS]",
      "spl_version": "10",
      "published_date": "2025-09-29"
    }
  },
  "productid": "69932-002_3f8e1fd0-31f4-4279-e063-6394a90abead",
  "productndc": "69932-002",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216023",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25ML (8-158mCi/ML)",
        "product_no": "001",
        "approval_date": "May 25, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLOTUFOLASTAT F-18",
  "proprietary_name": "POSLUMA",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA216023",
  "marketing_category": "NDA",
  "nonproprietary_name": "flotufolastat F-18",
  "start_marketing_date": "20230525",
  "active_numerator_strength": "158"
}

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