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LABELS · 4e98b8e6-01d4-48e8-87c4-7c6867279fa4

HICON

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
2025-01-21
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
Full extracted label fields
application numbers
  1. NDA021305
boxed warning exact
    brand names
    1. HICON
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=524a0dac-6e2b-2c0c-04b4-76d85dba63c5
    generic names
    1. SODIUM IODIDE I 131
    id
    4e98b8e6-01d4-48e8-87c4-7c6867279fa4
    indications and usage exact
    1. 1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Jubilant DraxImage Inc., dba Jubilant Radiopharma
      matched search terms
      1. carcinoma
      package ndcs
      1. 65174-880-25
      2. 65174-880-50
      3. 65174-880-00
      product ndcs
      1. 65174-880
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2 ) 06/2021 Contraindications ( 4 ) 06/2021 Warnings and Precautions ( 5 ) 06/2021
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00300.json
        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
        100
        skip
        300
        total
        830
        sha256
        bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=300&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%224e98b8e6-01d4-48e8-87c4-7c6867279fa4%22
        spl effective date
        2025-01-21
        spl effective time
        20250121
        spl set id
        524a0dac-6e2b-2c0c-04b4-76d85dba63c5
        spl version
        10
        substance names
        1. SODIUM IODIDE I-131
        uniis
        1. 29VCO8ACHH
        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
          NDA021305
          payload
          all indexed label documents
          1. Appl No
            021305
            Application Docs Date
            2003-01-24 00:00:00
            Application Docs ID
            15151
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            021305
            Application Docs Date
            2005-05-20 00:00:00
            Application Docs ID
            15152
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          3. Appl No
            021305
            Application Docs Date
            2006-01-10 00:00:00
            Application Docs ID
            15153
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          4. Appl No
            021305
            Application Docs Date
            2011-10-03 00:00:00
            Application Docs ID
            15154
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            27
            Submission Type
            SUPPL
          5. Appl No
            021305
            Application Docs Date
            2016-06-21 00:00:00
            Application Docs ID
            15155
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            41
            Submission Type
            SUPPL
          6. Appl No
            021305
            Application Docs Date
            2007-04-20 00:00:00
            Application Docs ID
            36625
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
            SUPPL
          7. Appl No
            021305
            Application Docs Date
            2008-03-05 00:00:00
            Application Docs ID
            36626
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          8. Appl No
            021305
            Application Docs Date
            2011-09-29 00:00:00
            Application Docs ID
            36627
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            25
            Submission Type
            SUPPL
          9. Appl No
            021305
            Application Docs Date
            2021-06-14 00:00:00
            Application Docs ID
            67773
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            47
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            12
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2003-01-24 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2003-08-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2004-11-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            021305
            Review Priority
            UNKNOWN
            Submission Class Code ID
            2
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2005-05-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            5
            Submission Status
            AP
            Submission Status Date
            2006-01-06 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            021305
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2006-04-04 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            10
            Submission Status
            AP
            Submission Status Date
            2006-10-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2007-04-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            021305
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            15
            Submission Status
            AP
            Submission Status Date
            2008-01-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            16
            Submission Status
            AP
            Submission Status Date
            2008-02-29 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2011-09-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            021305
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2011-10-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA021305
          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
          2021-06-11
          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
            021305
            Application Docs Date
            2021-06-14 00:00:00
            Application Docs ID
            67773
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            47
            Submission Type
            SUPPL
          official application record
          Appl No
          021305
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          JUBILANT
          openfda application present
          true
          products
          1. Active Ingredient
            SODIUM IODIDE I-131
            Appl No
            021305
            Drug Name
            HICON
            Form
            SOLUTION;ORAL
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            1-250mCi/0.25ML
            marketing status
            1. Discontinued
          2. Active Ingredient
            SODIUM IODIDE I-131
            Appl No
            021305
            Drug Name
            HICON
            Form
            SOLUTION;ORAL
            Product No
            003
            Reference Drug
            0
            Reference Standard
            0
            Strength
            1-500mCi/0.5ML
            marketing status
            1. Discontinued
          3. Active Ingredient
            SODIUM IODIDE I-131
            Appl No
            021305
            Drug Name
            SODIUM IODIDE I 131
            Form
            CAPSULE;ORAL
            Product No
            004
            Reference Drug
            0
            Reference Standard
            0
            Strength
            2-200mCi
            marketing status
            1. Discontinued
          4. Active Ingredient
            SODIUM IODIDE I-131
            Appl No
            021305
            Drug Name
            HICON
            Form
            SOLUTION;ORAL
            Product No
            005
            Reference Drug
            0
            Reference Standard
            0
            Strength
            1-1000mCi/ML
            marketing status
            1. Discontinued
          5. Active Ingredient
            SODIUM IODIDE I-131
            Appl No
            021305
            Drug Name
            SODIUM IODIDE I 131
            Form
            CAPSULE;ORAL
            Product No
            006
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.009-0.1mCi
            marketing status
            1. Prescription
          6. Active Ingredient
            SODIUM IODIDE I-131
            Appl No
            021305
            Drug Name
            HICON
            Form
            SOLUTION;ORAL
            Product No
            007
            Reference Drug
            1
            Reference Standard
            1
            Strength
            250-1000mCi
            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. NDA021305
        brand names
        1. HICON
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        260
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
        label id
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        source text sha256
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        current approval status
        not_reconciled
        duplicate text group
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        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. SODIUM IODIDE I 131
        id
        ind-span-a0ef6cd3729ff7a5fe82
        label id
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        positive predicate support span
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        end exclusive
        true
        exact text
        is indicated
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        offset unit
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        source field
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        source text sha256
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        start
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        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
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            source defined aliases
              source span
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              122
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.
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              source text sha256
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              start
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%224e98b8e6-01d4-48e8-87c4-7c6867279fa4%22
              spl effective date
              2025-01-21
              spl set id
              524a0dac-6e2b-2c0c-04b4-76d85dba63c5
              spl version
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              structured fields status
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              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
              tumor_directed_candidate
              Passage 2 · positive indication candidate
              application numbers
              1. NDA021305
              brand names
              1. HICON
              classification reasons
              1. explicit_positive_indication_predicate
              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
              pending
              content role
              positive_indication_candidate
              context span
              end
              260
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE HICON ® is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma. HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
              label id
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              offset unit
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              source text sha256
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              ind-span-ca1175e7baf0eb9b2891
              label id
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              positive predicate support span
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              true
              exact text
              is a radioactive therapeutic agent indicated
              label id
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              offset unit
              unicode_code_points
              source array index
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              source field
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              source text sha256
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              qualifier mentions
                regulatory links
                  schema version
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                  source batch sha256
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                  source defined aliases
                    source span
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                    end exclusive
                    true
                    exact text
                    HICON ® is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
                    label id
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                    offset unit
                    unicode_code_points
                    source array index
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                    source field
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                    source text sha256
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                    start
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                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%224e98b8e6-01d4-48e8-87c4-7c6867279fa4%22
                    spl effective date
                    2025-01-21
                    spl set id
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                    spl version
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                    structured fields status
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                    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
                    tumor_directed_candidate

                    Preserved source evidence · Not medical advice