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CERIANNA

Orange BookUNIISPLATC V09IX11

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

Identification

ManufacturerGE Healthcare Inc.
CountryUS (United States)
ATC codeV09IX11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7287400101
    50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)

Annotations

UNII (FDA Substance ID)
T32277KB09
FLUOROESTRADIOL F-18
RxCUI 2372221
Orange Book
N212155
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T32277KB09",
    "rxcui": "2372221",
    "inchikey": "KDLLNMRYZGUVMA-ZYMZXAKXSA-N",
    "display_name": "FLUOROESTRADIOL F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b2c2a2df-cf3e-4a29-a033-231ed5a94b58": {
      "match": "brand_token",
      "title": "CERIANNA (FLUOROESTRADIOL F 18) INJECTION [GE HEALTHCARE INC.]",
      "spl_version": "27",
      "published_date": "2026-03-20"
    }
  },
  "productid": "72874-001_fd28ffaf-5b17-43e7-bc91-fd623819340e",
  "productndc": "72874-001",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212155",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50ML (4-100mCi/ML)",
        "product_no": "001",
        "approval_date": "May 20, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOROESTRADIOL F-18",
  "proprietary_name": "CERIANNA",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA212155",
  "marketing_category": "NDA",
  "nonproprietary_name": "FLUOROESTRADIOL F 18",
  "start_marketing_date": "20200520",
  "active_numerator_strength": "100"
}

Related drugs

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