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LABELS · 46155dba-f0cf-22b8-e063-6294a90a5997

LIPIODOL

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-12-16
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ). WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY See Full Prescribing Information for complete Boxed Warning Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
Full extracted label fields
application numbers
  1. NDA009190
boxed warning exact
  1. WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ). WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY See Full Prescribing Information for complete Boxed Warning Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ).
brand names
  1. LIPIODOL
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=511d1f64-5cb9-4baa-a123-96205467e59a
generic names
  1. ETHIODIZED OIL
id
46155dba-f0cf-22b8-e063-6294a90a5997
indications and usage exact
  1. 1 INDICATIONS AND USAGE Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Guerbet LLC
    matched search terms
    1. carcinoma
    2. tumors
    package ndcs
    1. 67684-1901-1
    2. 67684-1901-2
    product ndcs
    1. 67684-1901
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Contraindications ( 4 ) 11/2022 Warnings and Precautions, Thyroid Dysfunction ( 5.4 ) 4/2022
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRA-ARTERIAL
    2. INTRALYMPHATIC
    3. INTRAUTERINE
    rxcuis
      source batch
      file
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      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
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      skip
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      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%2246155dba-f0cf-22b8-e063-6294a90a5997%22
      spl effective date
      2025-12-16
      spl effective time
      20251216
      spl set id
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      spl version
      13
      substance names
      1. ETHIODIZED OIL
      uniis
      1. KZW0R0686Q
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        NDA009190
        payload
        all indexed label documents
        1. Appl No
          009190
          Application Docs Date
          2014-04-08 00:00:00
          Application Docs ID
          10720
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        2. Appl No
          009190
          Application Docs Date
          2014-03-25 00:00:00
          Application Docs ID
          32992
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        3. Appl No
          009190
          Application Docs Date
          2020-06-12 00:00:00
          Application Docs ID
          63508
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          31
          Submission Type
          SUPPL
        4. Appl No
          009190
          Application Docs Date
          2020-06-12 00:00:00
          Application Docs ID
          63509
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
          Submission Type
          SUPPL
        5. Appl No
          009190
          Application Docs Date
          2023-04-10 00:00:00
          Application Docs ID
          73966
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          009190
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          2023-04-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          009190
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          31
          Submission Status
          AP
          Submission Status Date
          2020-06-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          009190
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2020-06-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          009190
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          27
          Submission Status
          AP
          Submission Status Date
          2018-09-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          009190
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2014-04-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          009190
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          22
          Submission Status
          AP
          Submission Status Date
          2014-01-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          009190
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2014-03-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          009190
          Review Priority
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          1985-09-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          009190
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          1979-11-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          009190
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          1979-11-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          009190
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          1978-02-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          009190
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1954-03-31 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA009190
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2023-04-05
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          009190
          Application Docs Date
          2023-04-10 00:00:00
          Application Docs ID
          73966
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          32
          Submission Type
          SUPPL
        official application record
        Appl No
        009190
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        GUERBET
        openfda application present
        true
        products
        1. Active Ingredient
          ETHIODIZED OIL
          Appl No
          009190
          Drug Name
          LIPIODOL
          Form
          OIL;INTRALYMPHATIC, INTRAUTERINE
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA009190
      brand names
      1. LIPIODOL
      classification reasons
      1. explicit_positive_indication_predicate
      2. diagnostic_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      527
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
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      current approval status
      not_reconciled
      duplicate text group
      dup-78936e12898aa88018b9
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ETHIODIZED OIL
      id
      ind-span-a5bd762fb0a212a8220d
      label id
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      exact text
      is an oil-based radio-opaque contrast agent indicated
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      qualifier mentions
      1. context exact
        aque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepa
        kind
        age
        polarity
        not_inferred
        span
        end
        123
        end exclusive
        true
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        source text sha256
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      2. context exact
        icated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use
        kind
        age
        polarity
        not_inferred
        span
        end
        145
        end exclusive
        true
        exact text
        adult
        label id
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        source text sha256
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      3. context exact
        : hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in
        kind
        age
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        not_inferred
        span
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        168
        end exclusive
        true
        exact text
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      4. context exact
        selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oi
        kind
        age
        polarity
        not_inferred
        span
        end
        234
        end exclusive
        true
        exact text
        adults
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      5. context exact
        aque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepa
        kind
        age
        polarity
        not_inferred
        span
        end
        374
        end exclusive
        true
        exact text
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      6. context exact
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      7. context exact
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        exact text
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      8. context exact
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        kind
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        end exclusive
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      regulatory links
        schema version
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        source batch sha256
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        source defined aliases
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          exact text
          1 INDICATIONS AND USAGE Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
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          source url
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          spl effective date
          2025-12-16
          spl set id
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          spl version
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          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          diagnostic_candidate

          Preserved source evidence · Not medical advice