Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 1e3a3004-3341-47e3-9961-0f8b966c3d1c

Levothyroxine Sodium

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
2019-10-01
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: Thyroid hormones, including Levothyroxine Sodium Tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Full extracted label fields
application numbers
  1. NDA021210
boxed warning exact
  1. WARNING: Thyroid hormones, including Levothyroxine Sodium Tablets, USP, either alone or with other therapeutic agents, should not be used for the treatment of obesity for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.
brand names
  1. Levothyroxine Sodium
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=434075d5-a82b-4f17-85e6-4c1922663dbc
generic names
  1. LEVOTHYROXINE SODIUM
id
1e3a3004-3341-47e3-9961-0f8b966c3d1c
indications and usage exact
  1. INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
indications and usage tables exact
    is original packager
      manufacturer names
      1. Proficient Rx LP
      matched search terms
      1. cancer
      package ndcs
      1. 71205-255-30
      2. 71205-255-60
      3. 71205-255-90
      product ndcs
      1. 71205-255
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 966249
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%221e3a3004-3341-47e3-9961-0f8b966c3d1c%22
        spl effective date
        2019-10-01
        spl effective time
        20191001
        spl set id
        434075d5-a82b-4f17-85e6-4c1922663dbc
        spl version
        2
        substance names
        1. LEVOTHYROXINE SODIUM
        uniis
        1. 9J765S329G
        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
        4. not_identified_as_original_packager
        Drugs@FDA application source records
        1. application number
          NDA021210
          payload
          all indexed label documents
          1. Appl No
            021210
            Application Docs Date
            2000-08-21 00:00:00
            Application Docs ID
            14639
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            021210
            Application Docs Date
            2008-02-14 00:00:00
            Application Docs ID
            36360
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            021210
            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56720
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
            17
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2000-08-21 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2000-12-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            021210
            Review Priority
            UNKNOWN
            Submission Class Code ID
            2
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2004-06-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            021210
            Review Priority
            UNKNOWN
            Submission Class Code ID
            2
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2004-12-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            021210
            Review Priority
            N/A
            Submission Class Code ID
            4
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2008-02-08 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2009-09-01 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2018-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            021210
            Review Priority
            STANDARD
            Submission Class Code ID
            4
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2014-09-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA021210
          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
          2018-12-10
          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
            021210
            Application Docs Date
            2018-12-12 00:00:00
            Application Docs ID
            56720
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
            SUPPL
          official application record
          Appl No
          021210
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          STEVENS J
          openfda application present
          true
          products
          1. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          2. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          3. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          4. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            004
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          5. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            005
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          6. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            006
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          7. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            007
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          8. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            008
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          9. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            009
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          10. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            010
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          11. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            011
            Reference Drug
            1
            Reference Standard
            1
            Strength
            0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            marketing status
            1. Prescription
          12. Active Ingredient
            LEVOTHYROXINE SODIUM
            Appl No
            021210
            Drug Name
            UNITHROID
            Form
            TABLET;ORAL
            Product No
            012
            Reference Drug
            1
            Reference Standard
            0
            Strength
            0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
            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 · unclassified context
        application numbers
        1. NDA021210
        brand names
        1. Levothyroxine Sodium
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
        pending
        content role
        unclassified_context
        context span
        end
        478
        end exclusive
        true
        exact text
        INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional
        label id
        1e3a3004-3341-47e3-9961-0f8b966c3d1c
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-cfc89db3f4b8b2fd7446
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. LEVOTHYROXINE SODIUM
        id
        ind-span-9adae51e6d5a016776bd
        label id
        1e3a3004-3341-47e3-9961-0f8b966c3d1c
        positive predicate support span
        Source null
        qualifier mentions
          regulatory links
            schema version
            0.1.0
            source batch sha256
            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
            source defined aliases
              source span
              end
              278
              end exclusive
              true
              exact text
              INDICATIONS AND USAGE Levothyroxine sodium is used for the following indications: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.
              label id
              1e3a3004-3341-47e3-9961-0f8b966c3d1c
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
              start
              0
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%221e3a3004-3341-47e3-9961-0f8b966c3d1c%22
              spl effective date
              2019-10-01
              spl set id
              434075d5-a82b-4f17-85e6-4c1922663dbc
              spl version
              2
              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
              unclear
              Passage 2 · unclassified context
              application numbers
              1. NDA021210
              brand names
              1. Levothyroxine Sodium
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              627
              end exclusive
              true
              exact text
              s: Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or w
              label id
              1e3a3004-3341-47e3-9961-0f8b966c3d1c
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
              start
              79
              current approval status
              not_reconciled
              duplicate text group
              dup-007e6644ecd811a293ef
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. LEVOTHYROXINE SODIUM
              id
              ind-span-8e360227cb2f7bc43387
              label id
              1e3a3004-3341-47e3-9961-0f8b966c3d1c
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                  source defined aliases
                    source span
                    end
                    427
                    end exclusive
                    true
                    exact text
                    Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
                    label id
                    1e3a3004-3341-47e3-9961-0f8b966c3d1c
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
                    start
                    279
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%221e3a3004-3341-47e3-9961-0f8b966c3d1c%22
                    spl effective date
                    2019-10-01
                    spl set id
                    434075d5-a82b-4f17-85e6-4c1922663dbc
                    spl version
                    2
                    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
                    unclear
                    Passage 3 · risk or warning
                    application numbers
                    1. NDA021210
                    brand names
                    1. Levothyroxine Sodium
                    classification reasons
                    1. risk_or_warning_words_without_positive_predicate
                    clinical review status
                    pending
                    content role
                    risk_or_warning
                    context span
                    end
                    857
                    end exclusive
                    true
                    exact text
                    during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute o
                    label id
                    1e3a3004-3341-47e3-9961-0f8b966c3d1c
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
                    start
                    228
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-8064d83c615d85bccfb5
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. LEVOTHYROXINE SODIUM
                    id
                    ind-span-635c1b51c5310b6127e0
                    label id
                    1e3a3004-3341-47e3-9961-0f8b966c3d1c
                    positive predicate support span
                    Source null
                    qualifier mentions
                    1. context exact
                      gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
                      kind
                      regimen
                      polarity
                      not_inferred
                      span
                      end
                      656
                      end exclusive
                      true
                      exact text
                      with or without the presence of goiter
                      label id
                      1e3a3004-3341-47e3-9961-0f8b966c3d1c
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
                      start
                      618
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                      source defined aliases
                        source span
                        end
                        657
                        end exclusive
                        true
                        exact text
                        Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.
                        label id
                        1e3a3004-3341-47e3-9961-0f8b966c3d1c
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
                        start
                        428
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%221e3a3004-3341-47e3-9961-0f8b966c3d1c%22
                        spl effective date
                        2019-10-01
                        spl set id
                        434075d5-a82b-4f17-85e6-4c1922663dbc
                        spl version
                        2
                        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
                        not_applicable
                        Passage 4 · risk or warning
                        application numbers
                        1. NDA021210
                        brand names
                        1. Levothyroxine Sodium
                        classification reasons
                        1. risk_or_warning_words_without_positive_predicate
                        clinical review status
                        pending
                        content role
                        risk_or_warning
                        context span
                        end
                        1103
                        end exclusive
                        true
                        exact text
                        ult from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
                        label id
                        1e3a3004-3341-47e3-9961-0f8b966c3d1c
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
                        start
                        458
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-486198ef695b7acde9be
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. LEVOTHYROXINE SODIUM
                        id
                        ind-span-83e3d3c68fbb6e0217ff
                        label id
                        1e3a3004-3341-47e3-9961-0f8b966c3d1c
                        positive predicate support span
                        Source null
                        qualifier mentions
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                            source defined aliases
                              source span
                              end
                              1103
                              end exclusive
                              true
                              exact text
                              Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS ), including thyroid nodules (see WARNINGS and PRECAUTIONS ), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS ), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
                              label id
                              1e3a3004-3341-47e3-9961-0f8b966c3d1c
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              7db89e56024b2e287f91c61cb2f004eb40b7cfda4c20092be7390201a110e1b7
                              start
                              658
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%221e3a3004-3341-47e3-9961-0f8b966c3d1c%22
                              spl effective date
                              2019-10-01
                              spl set id
                              434075d5-a82b-4f17-85e6-4c1922663dbc
                              spl version
                              2
                              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
                              not_applicable

                              Preserved source evidence · Not medical advice