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LABELS · 3a92e520-3da8-43be-9be2-63511c44b735

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
2024-12-06
Captured
2026-09-09T23:37:44.904352+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=fca88c97-5cd4-4834-ba87-deb5bd637788
generic names
  1. LEVOTHYROXINE SODIUM
id
3a92e520-3da8-43be-9be2-63511c44b735
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
    1. true
    manufacturer names
    1. Amneal Pharmaceuticals NY LLC
    matched search terms
    1. cancer
    package ndcs
    1. 69238-1830-1
    2. 69238-1830-7
    3. 69238-1831-1
    4. 69238-1831-7
    5. 69238-1832-1
    6. 69238-1832-7
    7. 69238-1833-1
    8. 69238-1833-7
    9. 69238-1834-1
    10. 69238-1834-7
    11. 69238-1835-1
    12. 69238-1835-7
    product ndcs
    1. 69238-1830
    2. 69238-1831
    3. 69238-1832
    4. 69238-1833
    5. 69238-1834
    6. 69238-1835
    7. 69238-1836
    8. 69238-1837
    9. 69238-1838
    10. 69238-1839
    11. 69238-1840
    12. 69238-1841
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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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.
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      2026-09-09
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%223a92e520-3da8-43be-9be2-63511c44b735%22
      spl effective date
      2024-12-06
      spl effective time
      20241206
      spl set id
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      spl version
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      substance names
      1. LEVOTHYROXINE SODIUM
      uniis
      1. 9J765S329G
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
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      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
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      1. Levothyroxine Sodium
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      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
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            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.
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            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
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                  Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism.
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                  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
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