Axumin

Orange BookUNIISPLATC V09IX12

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerBlue Earth Diagnostics

CountryUS (United States)

ATC codeV09IX12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6993200130
30 mL in 1 VIAL, MULTI-DOSE (69932-001-30)
ndc11
6993200150
50 mL in 1 VIAL, MULTI-DOSE (69932-001-50)

Annotations

UNII (FDA Substance ID)

38R1Q0L1ZE

FLUCICLOVINE F-18

RxCUI 1796118

Orange Book

N208054

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "38R1Q0L1ZE",
    "rxcui": "1796118",
    "inchikey": "NTEDWGYJNHZKQW-DGMDOPGDSA-N",
    "display_name": "FLUCICLOVINE F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "389a502e-a7d5-43dd-b6bf-f022ff23f3b9": {
      "match": "brand_token",
      "title": "AXUMIN (FLUCICLOVINE F-18) INJECTION, SOLUTION [BLUE EARTH DIAGNOSTICS]",
      "spl_version": "16",
      "published_date": "2025-03-10"
    }
  },
  "productid": "69932-001_2f9c7d6f-7f0f-f9dd-e063-6294a90abf59",
  "productndc": "69932-001",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "208054",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "9-221mCi/ML",
        "product_no": "001",
        "approval_date": "May 27, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUCICLOVINE F-18",
  "proprietary_name": "Axumin",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA208054",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluciclovine F-18",
  "start_marketing_date": "20160527",
  "active_numerator_strength": "221"
}

Related drugs

Other records sharing ATC code V09IX12.

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