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LABELS · 4dde84bb-3bd3-6722-e063-6394a90a4c09

Levothyroxine Sodium

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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
2026-03-25
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: NOT FOR TREATMENT OF OBESITY or FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine Sodium capsules, either alone or with other therapeutic agents, should not be used for the treatment of obesity or 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 [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ]. WARNING: NOT FOR TREATMENT OF OBESITY or FOR WEIGHT LOSS See full prescribing information for complete boxed warning Thyroid hormones, including Levothyroxine Sodium capsules, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life threatening manifestations of toxicity ( 6 , 10 ).

Indications and usage: exact source text

  1. 1 INDICATION AND USAGE Levothyroxine Sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism Levothyroxine Sodium capsules are indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine Sodium capsules are indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine Sodium capsules are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium capsules may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. Levothyroxine Sodium capsules are not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
Full extracted label fields
application numbers
  1. NDA021924
boxed warning exact
  1. WARNING: NOT FOR TREATMENT OF OBESITY or FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine Sodium capsules, either alone or with other therapeutic agents, should not be used for the treatment of obesity or 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 [see Adverse Reactions (6) , Drug Interactions (7.7) , and Overdosage (10) ]. WARNING: NOT FOR TREATMENT OF OBESITY or FOR WEIGHT LOSS See full prescribing information for complete boxed warning Thyroid hormones, including Levothyroxine Sodium capsules, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life threatening manifestations of toxicity ( 6 , 10 ).
brand names
  1. Levothyroxine Sodium
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d28d7202-1278-0486-e053-2995a90af286
generic names
  1. LEVOTHYROXINE SODIUM
id
4dde84bb-3bd3-6722-e063-6394a90a4c09
indications and usage exact
  1. 1 INDICATION AND USAGE Levothyroxine Sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism Levothyroxine Sodium capsules are indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine Sodium capsules are indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pediatric patients 6 years and older with thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: Levothyroxine Sodium capsules are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium capsules may induce hyperthyroidism [see Warnings and Precautions (5.4) ]. Levothyroxine Sodium capsules are not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. YARAL Pharma Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 82347-0055-4
    2. 82347-0060-4
    3. 82347-0005-4
    4. 82347-0010-4
    5. 82347-0015-4
    6. 82347-0020-4
    7. 82347-0025-4
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    9. 82347-0035-4
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    7. 82347-0025
    8. 82347-0030
    9. 82347-0035
    10. 82347-0040
    11. 82347-0045
    12. 82347-0050
    product types
    1. HUMAN PRESCRIPTION DRUG
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      spl effective date
      2026-03-25
      spl effective time
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      spl set id
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      spl version
      7
      substance names
      1. LEVOTHYROXINE SODIUM
      uniis
      1. 9J765S329G
      verification flags
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      Drugs@FDA application source records
      1. application number
        NDA021924
        payload
        all indexed label documents
        1. Appl No
          021924
          Application Docs Date
          2006-10-18 00:00:00
          Application Docs ID
          16575
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          021924
          Application Docs Date
          2007-12-27 00:00:00
          Application Docs ID
          16576
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          021924
          Application Docs Date
          2012-03-06 00:00:00
          Application Docs ID
          37883
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          021924
          Application Docs Date
          2017-12-11 00:00:00
          Application Docs ID
          50648
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        5. Appl No
          021924
          Application Docs Date
          2022-10-31 00:00:00
          Application Docs ID
          72501
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2006-10-13 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2008-01-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2007-12-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2012-03-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2013-07-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2017-04-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          021924
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2017-12-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          021924
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2022-06-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA021924
        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2022-06-22
        latest label selection rule
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        latest posted label documents
        1. Appl No
          021924
          Application Docs Date
          2022-10-31 00:00:00
          Application Docs ID
          72501
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
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        Sponsor Name
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        products
        1. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
          021924
          Drug Name
          TIROSINT
          Form
          CAPSULE;ORAL
          Product No
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          Reference Drug
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          Reference Standard
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          marketing status
          1. Prescription
        2. Active Ingredient
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          Appl No
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          Drug Name
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          Form
          CAPSULE;ORAL
          Product No
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          Reference Drug
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          marketing status
          1. Prescription
        3. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
          021924
          Drug Name
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          Form
          CAPSULE;ORAL
          Product No
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          Reference Drug
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          Reference Standard
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          marketing status
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        4. Active Ingredient
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          Product No
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        5. Active Ingredient
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          Appl No
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          Product No
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          Reference Standard
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          marketing status
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        6. Active Ingredient
          LEVOTHYROXINE SODIUM
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          Reference Drug
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          marketing status
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        7. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
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          Drug Name
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          marketing status
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        8. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
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          Drug Name
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          Product No
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          marketing status
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        9. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
          021924
          Drug Name
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          Product No
          010
          Reference Drug
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          Reference Standard
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          marketing status
          1. Prescription
        10. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
          021924
          Drug Name
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          Form
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          Product No
          011
          Reference Drug
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          Reference Standard
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        11. Active Ingredient
          LEVOTHYROXINE SODIUM
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          Drug Name
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          Form
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          Product No
          012
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          1
          Reference Standard
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          marketing status
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        12. Active Ingredient
          LEVOTHYROXINE SODIUM
          Appl No
          021924
          Drug Name
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          Form
          CAPSULE;ORAL
          Product No
          013
          Reference Drug
          1
          Reference Standard
          0
          Strength
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          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
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      brand names
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      exact text
      1 INDICATION AND USAGE Levothyroxine Sodium capsules are L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with: Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism ( 1 ) Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ( 1 ) Limitations of Use: Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients ( 1 ) Not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis ( 1 ) Hypothyroidism Levothyroxine Sodium capsules are indicated as a replacement therapy in adults and pediatric patients 6 years and older with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine Sodium capsules are indicated as an adjunct to surgery and radioiodine therapy in the management of adults and pedia
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