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United States · US · US:67684-1901_46155dba-f0cf-22b8-e063-6294a90a5997

LIPIODOL

Orange BookUNIISPL

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

Identification

ManufacturerGuerbet LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6768419011
    1 AMPULE in 1 CARTON (67684-1901-1) / 10 mL in 1 AMPULE
  • ndc11
    6768419012
    1 VIAL in 1 CARTON (67684-1901-2) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
KZW0R0686Q
ETHIODIZED OIL
RxCUI 4125
Orange Book
N009190
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KZW0R0686Q",
    "rxcui": "4125",
    "inchikey": null,
    "display_name": "ETHIODIZED OIL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTERIAL; INTRALYMPHATIC; INTRAUTERINE",
  "spl_meta": {
    "511d1f64-5cb9-4baa-a123-96205467e59a": {
      "match": "brand_token",
      "title": "LIPIODOL (ETHIODIZED OIL) INJECTION [GUERBET LLC]",
      "spl_version": "13",
      "published_date": "2025-12-17"
    }
  },
  "productid": "67684-1901_46155dba-f0cf-22b8-e063-6294a90a5997",
  "productndc": "67684-1901",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "009190",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHIODIZED OIL",
  "proprietary_name": "LIPIODOL",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA009190",
  "marketing_category": "NDA",
  "nonproprietary_name": "ethiodized oil",
  "start_marketing_date": "20140321",
  "active_numerator_strength": "480"
}

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